MAUDE Adverse Event Report: Ethicon Inc. Coated VICRYL; Suture, Absorbable, Synthetic

Catalog Number	VCP317H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an iliac artery stent implantation+lower limb angiography+iliac artery balloon angioplasty procedure on (b)(6)2026 and suture was used.The cardiovascular surgeon sutured the patient after surgery.The doctor opened the suture and found that the needle and suture were separated and unusable.The doctor immediately replaced the suture with a new one and continued suturing.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.The following information was requested, but unavailable: did this event contribute to any patient adverse event? received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.Device history review: a manufacturing record evaluation was performed for the finished device a manufacturing record evaluation was performed for the finished device 107d8d/(b)(6)and no non conformances / manufacturing irregularities related to the malfunction were identified.Mfg.Date: 03/30/2025 expiry date: 02/28/2030.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.

• Brand Name: Coated VICRYL
• Common Device Name: Suture, Absorbable, Synthetic
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): Ethicon Inc.-San Angelo; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50872719
• Report Number: 2210968-2026-09550
• Device Sequence Number: 13089801
• Product Code: GAM
• UDI-Device Identifier: 10705031052253
• UDI-Public: (01)10705031052253(17)300228(10)107D8D
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K181652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP317H
• Device Lot Number: 107D8D
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2025
• 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
• Patient Sex: Unknown