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

Model Number 190030

Device Problems Mechanical Problem (1384); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Reportedly, on three separate occasions and three separate patients, while obtaining a biopsy from myocardial tissue and attempting to pull the biopsy forcep out of the body, the forceps would not close.Reportedly, in one of the patients the sheath had to be removed and replaced in order to remove the forceps safely.Reportedly, there was no harm to any of the patients.

• 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: 7369302
• MDR Text Key: 103416736
• Report Number: 7369302
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 00886333206711
• UDI-Public: (01)00886333206711(17)221130
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2022
• Device Model Number: 190030
• Device Catalogue Number: 190030
• Device Lot Number: 3974116
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2018
• Type of Device Usage: N
• Patient Sequence Number: 1