MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 8X18IN 0 S/A CTB CR; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDPB750D
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a pancreaticoduodenectomy on an unknown date and suture was used on the fascia.Two days post-op, when the patient coughed, the abdominal wall opened.Wound dehiscence occurred.An emergency reoperation was performed.The surgeon opined that the suture was not the cause.It was reported that the suture might have loosened during suturing.It was stated that because the suture was untied, the surgeon thinks that the suture method was not appropriate.Current status of the patient was reported as in the hospital.Additional information was requested.
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.(b)(4).Attempts are being 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.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? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what tissue dehisced? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? onset date/time of dehiscence? (# post op days/date if available) how was the dehiscence managed? please describe any surgical intervention required for the wound dehiscence including date and findings.Please describe the appearance of the suture during the second procedure.Did the suture knots un-tie post-op? were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? 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? if applicable, will product be returned? if so, please provide the return date and tracking information.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/22/2022.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 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.Unknown.Date of index surgical procedure? unknown.The diagnosis and indication for the index surgical procedure? unknown.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? unknown.What tissue dehisced? fascia.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.How was the suture placed (interrupted or continuous)? interrupted.How was the suture tied (square knot or multiple knots one end)? unknown.Onset date/time of dehiscence? (# post op days/date if available).Pst op 2 days.How was the dehiscence managed? re-operation was performed.Please describe any surgical intervention required for the wound dehiscence including date and findings.The suture got loose.Please describe the appearance of the suture during the second procedure.The suture got loose.Were there any precipitating stress factors for the sutures untying, breakage or pulling out of the tissue? unknown.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the surgeon thinks the suture was not the cause of the event but this rarely happens so wants to know what was the cause.What is the patient's current status? the patient is in the hospital.Lot number? unknown.If applicable, will product be returned? if so, please provide the return date and tracking information.No sample will be returned.

• Brand Name: PDS+ VIO 8X18IN 0 S/A CTB CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15272262
• Report Number: 2210968-2022-06821
• Device Sequence Number: 12209085
• Product Code: NEW
• UDI-Device Identifier: 10705031218833
• UDI-Public: 10705031218833
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 09/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDPB750D
• Device Catalogue Number: PDPB750D
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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: Unknown