MAUDE Adverse Event Report: ARTHROCARE CORPORATION FIRSTPASS SUTURE PASSER

Catalog Number 22-4035

Device Problem Installation-Related Problem (2965)

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

Event Date 08/14/2018

Event Type  malfunction  

Event Description

It was reported that assembling the firstpass needle is difficult and when attempting to pass the needle through tissue, the suture is not working appropriately.The piece that holds the self-capture is loose.No backup device was available.Nor significant delay or patient injury reported.

Manufacturer Narrative

The reported firstpass suture passer device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer complaint cannot be confirmed.From the information provided, assembling the firstpass needle is difficult and when attempting to pass the needle through tissue, the suture is not working appropriately.The piece that holds the self-capture is loose.An exact root cause cannot be determined without evaluation of the device.Potential failure factors unrelated to manufacturing may be due to excessive use and/ or incorrect suture capture loading/ unloading technique which can result in device failure.The firstpass device is a reusable device; therefore normal wear and tear can be expected.

• Brand Name: FIRSTPASS SUTURE PASSER
• Type of Device: PASSER
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7828950
• MDR Text Key: 118744357
• Report Number: 3006524618-2018-00439
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22-4035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly