MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL POLYESTER SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number XZW10B55

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.

Event Description

It was reported that the patient underwent aortic valve replacement procedure on (b)(6) 2016 and suture was used.During the procedure, it was found that the pledget¿s size is uneven and not matching up.A like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was available.

Manufacturer Narrative

The dispensed suture was examined for visual inspection and it was observed a threading pledget on the suture piece.The dimensions of the pledget meet the requirements, however was observed damaged and bent in the middle of the pledget (the pledget has lost its rectangular shape).Additionally, body fluids were observed along of the strand and on the pledget.It could not be determined what may have caused the pledget has lost its rectangular shape.

• Brand Name: ETHIBOND EXCEL POLYESTER SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6120355
• MDR Text Key: 60649518
• Report Number: 2210968-2016-15073
• Device Sequence Number: 1
• Product Code: GAT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: XZW10B55
• Device Lot Number: KE6431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2016
• 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