MAUDE Adverse Event Report: ETHICON INC. SFXSYM PDS+ UNI VIO 18IN 1 SA CTXB; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Swelling/ Edema (4577)
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.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 date of index surgical procedure? the diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? when beginning the running suture, did the surgeon take the first pass above or adjacent to the incision in a direction away from the incision? after taking the first pass away from the incision, did the surgeon then take a pass of tissue perpendicular to the initial pass? if so, how many perpendicular passes? did the surgeon then proceed with wound closure in the opposite direction of the first pass? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? what tissue dehisced? please describe the appearance of the suture during the second procedure ? did the suture break post-op? if so, where was the break noted (termination, middle, end)? were there any patient stress factors that precipitated the edema and wound dehiscence? onset date/time of edema and wound dehiscence? (# post op days) please describe any surgical intervention required for the wound dehiscence including date and findings.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? 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?.
Event or Problem Description
It was reported that a patient underwent wound closure for ventral midline celiotomy on an unknown date and barbed suture was used.The patient developed severe edema, the tissue tore and the wound dehiscence.After dehiscence, it was abdominal closure with a different type of interrupted suture.There were no problems with the subsequent process.Additional information was requested.
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure¿unk date of index surgical procedure?¿unk the diagnosis and indication for the index surgical procedure? ¿the name of procedure was open pancreatic dissection on what tissue was the suture used?¿fascia what was the tissue condition (normal, thin, calcified, fragile, diseased)?¿the patient have serious edema when beginning the running suture, did the surgeon take the first pass above or adjacent to the incision in a direction away from the incision?¿yes after taking the first pass away from the incision, did the surgeon then take a pass of tissue perpendicular to the initial pass? if so, how many perpendicular passes?¿yes did the surgeon then proceed with wound closure in the opposite direction of the first pass?¿yes was the fixation tab seated against the tissue at the initiation of suture use during the index procedure?¿yes were two reverse stitches performed across the incision prior to closure?¿yes what tissue dehisced?¿fascia please describe the appearance of the suture during the second procedure ? ¿not broken did the suture break post-op? if so, where was the break noted (termination, middle, end)?¿not broken were there any patient stress factors that precipitated the edema and wound dehiscence? ¿the patient have serious edema, and the surgeon thought the patient status led to this event onset date/time of edema and wound dehiscence? (# post op days)¿several days post-op please describe any surgical intervention required for the wound dehiscence including date and findings.¿re-closure did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?¿no what symptoms did the patient experience following the index surgical procedure? onset date?¿dehiscence other relevant patient history/concomitant medications?¿edema what is the physician¿s opinion as to the etiology of or contributing factors to this event? ¿the patient have serious edema, and the surgeon thought the patient status led to this event what is the patient's current status?¿no problem lot number? =>unk surgeon¿s name?¿unk i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.

• Brand Name: SFXSYM PDS+ UNI VIO 18IN 1 SA CTXB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19639996
• Report Number: 2210968-2024-06787
• Device Sequence Number: 7156514
• Product Code: NEW
• UDI-Device Identifier: 10705031219359
• UDI-Public: 10705031219359
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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,Followup
• Report Date (Section B): 07/25/2024

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: SXPP1A300
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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