MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Unspecified Tissue Injury (4559)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.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.Additional information was requested, and the following was obtained: the surgeon had to revise the surgery as patient had a leak.Surgeon thought patient drank too much water and put pressure on the tissue and mentioned the patient didn't have great tissue but has felt since that the tissue may have been torn by the stratafix suture.When i spoke to the surgeon yesterday, she indicated that the icu at (b)(6) hospital had overloaded the patient with fluid x 3litres and she had to transfer the patient back to calvary bruce private to revise the surgery because of that issue.She did not mention to me anything about the sutures.I will investigate further regarding your questions as this seems to be something the surgeon has faced twice regarding fluid volume.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.How many 2/0 x15cm stratafix sutures sxpp1b415 tore through the tissue at the gi anastomosis? how many 0 x45cm stratafix sutures tore through the tissue at the gi anastomosis? in addition to the initial gastric bypass surgery on (b)(6) 2022, how many revision surgeries did the patient undergo? please provide dates and results.Please provide the patient's age, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history besides diabetes/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product code and lot number for each suture that contributed to the tear in the gastric tissue? if applicable, will product be returned? if so, please provide the return date and tracking information.Related medwatch reports: 2210968-2022-06292, 2210968-2022-06294.
Event or Problem Description
It was reported that a patient underwent a gastric bypass procedure on (b)(6) 2022 and barbed suture was used.The tissue was torn at the gj anastomosis and the surgeon opines that it is associated with the barbed suture.The patient required revision surgery.Additional information was requested.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15166716
• Report Number: 2210968-2022-06293
• Device Sequence Number: 19360271
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: 10705031235885
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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 Model Number: SXPP1B415
• Device Catalogue Number: SXPP1B415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2022
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female