MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 9IN 2-0 S/A CT-2; SUTURE, ASBOSRBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B444
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (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.Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (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.H6 component code: g07002 device not returned.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index s.Urgical procedure? date of the gastric neruo stimulator implant with a pilora plasty? date of the neuro stimulator removal? was the stratafix spiral used in both procedures? was the stratafix spiral used in gastric neruo stimulator implant with a pilora plasty? if yes, on what tissue was the suture used? was the stratafix spiral used in neuro stimulator removal? if yes, on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? 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? where was the gastric leak? was the suture used at the site of the gastric leak? was the gastric leak considered an anastomotic leak? please describe any medical/surgical intervention required for this suture event including dates and results.Did the stratafix suture break? if so, where was the break noted (termination, middle, end)? can you describe the appearance of the stratafix suture during second procedure, if applicable? were there any patient stress factors that may have contributed to the gastric leak? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/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? lot number? surgeon¿s name? will the product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient underwent procedure on (b)(6) 2024 and a barbed suture was used.One week post-op of a gastric neruostimulator implant with a piloraplasty, the patient underwent a neuro stimulator removal.Both those cases were robotic.The patient returned for a gastric leak.Four leak tests were performed.They confirmed there was a gastric leak but were unable to confirm where the leak was occurring from.The patient was sent to gi to get a stint.Additional information was requested.

• Brand Name: SFX SPI MCRYL+UNI VIO 9IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ASBOSRBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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 PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19585177
• Report Number: 2210968-2024-06488
• Device Sequence Number: 7326410
• Product Code: GAM
• UDI-Device Identifier: 10705031470064
• UDI-Public: 10705031470064
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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: SXMP1B444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown