MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. JAWZ EMB FORCEPS; ENDOMYOCARDIAL BIOPSY FORCEPS

Catalog Number 190051

Device Problem Protective Measures Problem (3015)

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

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing and a follow up report will be submitted once the evaluation is complete.

Event Description

Coating not fixed at the end, therefore exposing the inner coil that grasped cardiac tissue.

Manufacturer Narrative

A review of returned product from the customer was performed, initial actuation of the device was not possible.However, it was noted that with the device being inoperable due to bioburden, that the distal tip would protrude past the fep coating, if the finger rings were pushed forward.Soaking the tip of the device in alcohol for thirty minutes, with occasional attempts at actuation, caused multiple pieces of bioburden to expel from the distal tip (clevis mechanism).Once debris was cleared from the device it actuated, including under stress of bending the tip per ifu.It was also noted that with normal pressure the forceps would open as designed, but excessive pressure would again cause the distal tip to protrude past the fep coating.The complaint was confirmed.An exact root cause could not be determined with confidence, however the most likely cause of this issue was excess pressure applied to the finger rings while the device was inoperable due to bioburden build up.This caused the distal tip to be forced past the end of the fep coating due to mechanical leverage.The ifu for this device states "continuous flushing of the introducer sheath or guiding catheter with heparinized saline should be conducted while slowly withdrawing the biopsy forcep/specimen".This issue was most likely caused by an incident in the operating facility, therefore no corrective is needed.

• Brand Name: JAWZ EMB FORCEPS
• Type of Device: ENDOMYOCARDIAL BIOPSY FORCEPS
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 9226800
• MDR Text Key: 182303661
• Report Number: 1625425-2019-00272
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): Y
• PMA/PMN Number: K951447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 190051
• Device Lot Number: 4155451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR