MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. 16G X 10CM BIOPINCE¿ AUTOMATIC FULL CORE BIOPSY INSTRUMENT

Catalog Number 370-1080-01

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records was conducted and no similar concerns were found.Four devices were returned for review.The devices were examined and test fired with no firing issues noted.However, all of the devices exhibited pincer damage which would prevent the devices from taking samples successfully.Pincer damage can occur as a result of hitting hard or calcified tissue, handling of the device during use, such as tilting the needle to extract the sample onto a slide, or during reinsertion into a coaxial needle.These possible root causes occur during use of the device.Pincer damage may also occur if the pincer does not properly enter the device inner coring cannula slot (window).Therefore, argon r&d has decided to review the issue to determine if any changes can be made to improve the overall performance of the device.During manufacture of the devices, there are several inspections to ensure the proper shape of the pincer and to ensure the overall proper function of the device.

Event Description

The pincer does not go into the window.Lays outside, or bent outwards, and no biopsies taken.Happens with and without use of coaxial needles.Biopsy ¿ muscle ¿ upper leg.After the doctor fired biopince into the muscle, it was difficult to remove.This have led to complications (i.E.Bleedings & pain).In at least one occasion, biopince had to be cut out.

• Brand Name: 16G X 10CM BIOPINCE¿ AUTOMATIC FULL CORE BIOPSY INSTRUMENT
• Type of Device: AUTOMATIC FULL CORE BIOPSY INSTRUMENT
• 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: 8397150
• MDR Text Key: 138574871
• Report Number: 1625425-2019-00033
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): Y
• Reporter Country Code: DA
• PMA/PMN Number: K904987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: 370-1080-01
• Device Lot Number: 11195135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Is the Reporter a Health Professional?: Yes
• 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: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention