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

Catalog Number 190081

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records and inspection records was conducted and no similar concerns were found.No samples or photos were returned, so the issue could not be confirmed.Since the sample is not available for return and there were no concerns noted in the manufacturing documentation, no further evaluation can be conducted at this time.

Event Description

The insulation right behind the tip came free when the user pulled back on the handle.Of course, this happen while in the heart.The user thinks the spring was caught on the tricuspid valve.It took about five minutes of manipulating and the user was finally able to free it without ripping the valve.

• 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
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6840486
• MDR Text Key: 85371429
• Report Number: 1625425-2017-00121
• Device Sequence Number: 1
• Product Code: DWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 190081
• Device Lot Number: G38301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1