Device Description - Joline 11726 Instrucciones De Uso

Contents
1.

Device description

1.1 General device description, clinical benefit and mode of operation
1.2 Performance features/ technical specification
1.3 Compatibility with other devices
2. Indication
3. Contraindication
4. Complications
5. Patient group
6. User profile
7. Environment for use
8. Warnings and precautions
9. Packaging, shelf life, storage and disposal
10. Summary of safety and clinical performance
11. Reporting obligations for severe incidents
12. Use
1. Device description
1.1 General device description, clinical benefit and mode of operation
The Biopsy Forceps Knipsa (referred to in the following as the 'device') are radiopaque endomyocardial forceps (also called a bioptome) for
taking tissue samples from the ventricle walls inside the heart (endomyocardium). The device is supplied sterile and pyrogen-free. The grip
can be freely rotated. A bend indicator is provided on the grip. This allows the user to more easily guide the shaft, which has already been
pre-bent.
This is a single-use device which is intended for use in a single intervention. The intervention usually involves approx. 4-6 tissue samples being
taken from different regions of the ventricles.
The device consists of the main components/functional elements shown in Figure 1.
The tissue samples taken in an endomyocardial biopsy are used for follow-up monitoring in heart transplants and for the diagnosis of
suspected heart muscle inflammation (myocarditis), cardiac storage disease (e.g. amyloidosis) or cardiomyopathy. For this monitoring and
diagnosis, the tissue samples obtained are analysed histologically, using electron microscopy, immunohistochemically or by molecular bio-
logy. In this way, a diagnosis can be made and therapeutic approaches can be defined.
Using the grip [1], the user can open and close the cutting jaws [3] of the biopsy forceps with one hand by exerting force on the thumb ring
and the Bowden cable inside the shaft [2] (Figures 2.1 and 2.2).
1.2 Performance features/ technical specification
REF Configuration
KNIPSA500 Pre-bent
1.3 Compatibility with other devices
The Biopsy Forceps Knipsa are inserted into the vascular system through a 6 Fr. sheath. The sheath must be provided by the user. Where ne-
cessary, the sheath must have the required equipment for continuous flushing or intermittent flushing with sterile physiological saline solution
(NaCl 0.9%). It is compatible with the AVANTI™+ sheath introducer system (Cordis Corp.), for example.
2. Indication
The Biopsy Forceps Knipsa are used to take tissue samples from the endomyocardium (right ventricle).
3. Contraindication
There are no absolute contraindications known for the use of the Biopsy Forceps Knipsa in an endomyocardial biopsy.
However, relative contraindications should be mentioned which need to be weighed up on a case-by-case basis by the user with regard to the
risk/benefit assessment for the prognosis of the patient. These include:
a) Ventricular aneurysms
b) Covered perforations of the right ventricle
c) Disrupted coagulation status of the patient
Usable length Cutting jaws size
50 cm 1.80 mm
EN - ENGLISH
Cutting jaws Recommended sheath
volume size
3
2.42 mm 6 Fr (2.00 mm)
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