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

Catalog Number 190051

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the package device history record and inspection records was conducted and no similar concerns were found.The returned device was evaluated and the issue was confirmed since the biopsy jaws do not open.This product is purchased fully packaged from a supplier.A supplier corrective action request has been sent to the supplier.A follow-up report will be submitted when the supplier provides their evaluation and conclusions.

Event Description

Patient admitted for cardiac biopsy to rule out amyloidosis.Upon attempt to retrieve tissue sample the endomyocardial biopsy forcep became stuck in the superior vena cava (svc) right atrial junction and failed to open or release despite multiple attempts to open up.Patient was subsequently admitted emergently to the operating room where a sternotomy and small venotomy was completed to remove the biopsy forcep.

Manufacturer Narrative

A review of the device batch record was performed for (b)(4), in-process and finished goods and there were no non-conformances or capas opened in relation to the nature of the complaint.All devices met all (b)(4), in-process and finished goods specifications upon release of the product.The returned device was evaluated by the supplier.Per the supplier, ¿the device was returned with the introducer still attached.The introducer was removed and the device was laid across the work bench.There were several severe bends in the outer jacket caused by over-actuation.The forceps would not open.The distal end of device was inspected under 10x magnification and it was clear that there was dried fluid preventing the jaws from opening.The jaws were soaked in hydrogen peroxide and the dried fluids were removed with a razor blade.Once a significant amount of dried fluid was removed, the jaws were able to open and close when actuated.These devices are functionally tested 100% prior to packaging.There is no root cause investigation at this time.Once the device was cleaned with hydrogen peroxide the jaws were able to open and close as intended even with the bends in the outer jacket.¿.

• 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: 6573438
• MDR Text Key: 75432111
• Report Number: 1625425-2017-00072
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 190051
• Device Lot Number: G14888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2016
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 74