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

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2018

Event Type  malfunction  

Event Description

Reportedly, during a myocardial biopsy when inserting the argon biopsy forcep into the sheath and while squeezing the handle to get a piece of the right ventricle, the spring in the handle snapped leaving the forceps in the open position.An x-ray was used to help remove the forceps, given the forcep was stuck in an open position.Reportedly, all the pieces were recovered and the forceps were able to be removed.No patient harm reported.

• 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: 7446217
• MDR Text Key: 106023907
• Report Number: 7446217
• Device Sequence Number: 1
• Product Code: DWZ
• 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: 04/16/2018,04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Other Device ID Number: FORCEP BIOPSY 2.4MM X 50CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR