MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 1 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP959H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2021
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The patient demographic info: age, weight, bmi at the time of index procedure.Date of the index surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was suture initially placed (interrupted or continuous)? was there any precipitating stress factor 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 re-operation? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? has product been returned? if so, please provide the return date and tracking information.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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 472 g/m.
Event or Problem Description
It was reported that a patient underwent a routine c-section on an unknown date in 2021 and suture was used to close the fascial layer of the abdominal wall.The surgery was completed successfully and the patient was hospitalized post-op.A day after the surgery, while the patient was in hospitalization, a gap was noticed in the wound and parts of intestine were visible.The patient underwent an emergency surgery when it was found that both knots were secured but the suture was torn in the middle due to high pressure.The patient was operated on and closed.The surgeon has mentioned that the technique was normal and it is unclear why the suture was torn and the fascia opened.The head surgeon opine that according to the problem is probably not in the suture itself and this is a rare event.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 03/26/2021.H3 analysis summary: sixteen unopened samples of product code vcp959h were received for evaluation.Visual inspection of the unopened samples was performed and no defects were found on the packages.The samples were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no defects, damage, or suture breakage were noted.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.The device performed without any defect noted.H6 component code: g07002 - unopened samples.A manufacturing record evaluation was performed for the finished device qh2acl and no non conformances / manufacturing irregularities related to the malfunction were identified.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 ¿ = 472 g/m.

• Brand Name: VCL+ UD 36IN 1 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11529777
• Report Number: 2210968-2021-02558
• Device Sequence Number: 20189788
• Product Code: GAM
• UDI-Device Identifier: 10705031056237
• UDI-Public: 10705031056237
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2021

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 Expiration Date: 06/30/2025
• Device Model Number: VCP959H
• Device Catalogue Number: VCP959H
• Device Lot Number: QH2ACL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 08/11/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 03/26/2021; 08/31/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention