MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A301

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Not Applicable (3189)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional information was requested and the following was obtained: reoperation was performed, and the patient¿s condition became stable postoperatively.The stratafix which had been used during the primary operation could not be found on the sutured area during the reoperation.- the surgeon commented there is a possibility that the tissue was torn by the stratafix because the patient¿s tissue on which the stratfix was used was thinner than usual.What tissue was the stratafix symmetric suture used on? => no information.What was the condition of the tissue when the suture was placed (diseased, weak, healthy)? =>no information.How was the stratafix symmetric placed? =>no information.Was the fixation tab intact when the suture was placed in the patient? =>no information.Can you explain ¿stratafix which was used in primary surgery became loose¿? =>the stratafix was used in the primary operation.During the reoperation, it was found that the stratafix was loose.Was the air leakage persistent or new at leak at 3 weeks post op? =>the doctor found it at 3 weeks post op.What was the indication for the re-operation? =>it was found that the stratafix was loose.Air leak was observed.What was the date of the second procedure? => (b)(6) 2018.Could you describe the appearance of the suture during the second procedure? =>it was loose.Was the suture intact and pulled through the tissue? =>the doctor couldn't find the stratafix, so it wasn't retrieved from patient.Do you have the status of suture for evaluation? =>no.The suture was lost during the reoperation.What is the current condition of the patient? => the patient has been stable since the reoperation.".

Event Description

It was reported that a patient underwent right lower lobe resection procedure on (b)(6) 2018 and barbed suture was used.The patient complained of poor health and returned to the hospital three weeks post op.A second procedure was performed on (b)(6) 2018 and air leakage was observed.The surgeon observed that the barbed suture became loose and opined that there is a possibility that the tissue was torn by the barbed suture because the patient¿s tissue on which the suture was used was thinner than usual.The patient condition is reported as stable.Additional information has been requested.

• Brand Name: SFX SYM PDS+ VIO 18IN 1 S/A CTB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7639224
• MDR Text Key: 112412689
• Report Number: 2210968-2018-73846
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227712
• UDI-Public: 10705031227712
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113004
• 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
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention