MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 G/W; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PXX43
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? when referring to the tab, please clarify did the pledget break into 3 pieces? was there any precipitating stress factor for the tab breakage? what was tissue location of the placement of suture? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? did the operating surgeon observe any suture deficiency or anomaly before or during use? lot # of the product involved in the event? if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event was the patient¿s treatment altered in any way due to the prolonged surgery time? if yes, please explain was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? what is the patient current status?.
Event or Problem Description
It was reported that a patient underwent a mitral valve replacement procedure on (b)(6) 2017 and suture was used.During the procedure the tab broke into three pieces and fell off.One piece was retrieved and the other two pieces fell off in the blood vessel.The pieces could not be retrieved.Another new device was changed to complete the procedure.The operation time was prolonged about two hours.The patient condition is stable.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).An opened msda folder with five needle-suture combinations of product code pxx43 were sent for analysis.This product code is multi-strand during the visual inspection of the opened sample, five needle-suture combinations were observed into the msda folder.The strands were winding correctly and the strands were dispensed without problems, but in the inspection of the pledgets were noted bending since, they have lost its rectangular shape in four samples.According to the condition of the sample received after threading and/or winding, the pledgets have lost its rectangular shape.

• Brand Name: ETHIBOND EXCEL SUTURE 30"(75CM) 2-0 G/W
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7233906
• Report Number: 2210968-2018-70588
• Device Sequence Number: 1994751
• Product Code: GAT
• UDI-Device Identifier: 10705031049314
• UDI-Public: 10705031049314
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PXX43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention