ENDOMYOCARDIAL BIOPSY FORCEP
Received Mar 1, 2022 · Event occurred Jan 25, 2022
Report 13633932 · MDR key 13633932
Device
Generic name
Device, Biopsy, Endomyocardial
Manufacturer
Argon Medical Devices, Inc.Model number
190030Catalog number
190030
Lot number
5180239
Product problems
- Break
- Difficult to Remove
Patient
16060 DA · Male
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE BIOPSY FORCEP IS A LONG CATHETER THAT HAS A HANDLE ON THE END, THE HANDLE IS CONNECTED TO THE FORCEPS AT THE OTHER END OF THE CATHETER BY A WIRE INSIDE THE CATHETER, THIS ALLOWS THE FORCEPS TO BE OPENED AND CLOSED INSIDE THE HEART FROM OUTSIDE THE BODY. PART OF THIS MECHANISM BROKE, MAKING IT DIFFICULT TO CONTROL THE OPENING AND CLOSING OF THE FORCEPS. THIS, IN TURN, MADE REMOVAL OF THE FORCEPS FROM THE BODY VIA THE SHEATH DIFFICULT. A HEMOSTAT WAS USED TO CONTROL THE DEVICE IN A WAY THAT FACILITATED THE REMOVAL OF THE DEVICE SUCCESSFULLY.
Description of Event or Problem
THE BIOPSY FORCEP IS A LONG CATHETER THAT HAS A HANDLE ON THE END, THE HANDLE IS CONNECTED TO THE FORCEPS AT THE OTHER END OF THE CATHETER BY A WIRE INSIDE THE CATHETER, THIS ALLOWS THE FORCEPS TO BE OPENED AND CLOSED INSIDE THE HEART FROM OUTSIDE THE BODY. PART OF THIS MECHANISM BROKE, MAKING IT DIFFICULT TO CONTROL THE OPENING AND CLOSING OF THE FORCEPS. THIS, IN TURN, MADE REMOVAL OF THE FORCEPS FROM THE BODY VIA THE SHEATH DIFFICULT. A HEMOSTAT WAS USED TO CONTROL THE DEVICE IN A WAY THAT FACILITATED THE REMOVAL OF THE DEVICE SUCCESSFULLY.