MAUDE Adverse Event Report: ETHICON INC. NON ABSORBABLE SURGICAL SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number PNW617

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot v8001, and no non-conformances were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported: "the suture attached near the pledget also damaged and the size is uneven.Please clarify: do you mean that the suture is damaged and its size is uneven? or do you mean the suture size is uneven as in mixed suture, a suture so uneven in size which means from a different product family? when it says size is uneven do you mean suture length is uneven or suture diameter is uneven? device return status follow up? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a valve repair on (b)(6) 2020 and suture was used.During the procedure, it was noted that the pledget size was different.There were no adverse patient consequences.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 07/16/2020 corrected information: b1, h1- upon additional information review, this medwatch report 2210968-2020-04782 is being voided as it no longer meets malfunction reportability criteria.

• Brand Name: NON ABSORBABLE SURGICAL SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10188458
• MDR Text Key: 196219113
• Report Number: 2210968-2020-04782
• Device Sequence Number: 1
• Product Code: GAT
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: PNW617
• Device Lot Number: V8001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Patient Sequence Number: 1