MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ENDOMYOCARDIAL BIOPSY FORCEP; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number 190030

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

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.

Event Description

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.

• Brand Name: ENDOMYOCARDIAL BIOPSY FORCEP
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 13633932
• MDR Text Key: 286339436
• Report Number: 13633932
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190030
• Device Catalogue Number: 190030
• Device Lot Number: 5180239
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Male