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

Model Number	190030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 7369302
• Report Number: 7369302
• Device Sequence Number: 16282444
• Product Code: DWZ
• UDI-Device Identifier: 00886333206711
• UDI-Public: (01)00886333206711(17)221130
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018
• Report Date (Section F): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2018
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/22/2018