MAUDE Adverse Event Report: COVIDIEN SURGICAL POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	CL-914
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	12/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, intra-operatively, after the delivery of the fetus and the removal of the placenta, the primary surgeon used suture to perform continuous closure of the abdominal fascia.After properly tying and securing the suture, the swage end of the suture suddenly broke while continuing closure, causing the previously closed fascia to loosen.There was slight tissue bulging at the incision, and a small amount of oozing.The physician immediately stopped the procedure to assess the situation.The team replaced the suture with another model and continued the closure.The bleeding was controlled by compression.The operation time was prolonged by 30 minutes, but the patient recovered well postoperatively and was discharged only one day later than planned.
Additional Manufacturer Narrative
Additional information: b5, g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a caesarian section procedure, after the delivery of the fetus and the removal of the placenta, the primary surgeon used suture to perform continuous closure of the abdominal fascia.After properly tying and securing the suture, the swage end of the suture suddenly broke while continuing closure, causing the previously closed fascia to loosen.There was slight tissue bulging at the incision, and a small amount of oozing.The physician immediately stopped the procedure to assess the situation.The team replaced the suture with another model and continued the closure.The bleeding was controlled by compression.The operation time was prolonged by 30 minutes, but the patient recovered well postoperatively and was discharged only one day later than planned.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24175933
• Report Number: 1219930-2026-00442
• Device Sequence Number: 15858951
• Product Code: GAM
• UDI-Device Identifier: 10884521043329
• UDI-Public: (01)10884521043329(17)300131(10)A5B1689Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: CL-914
• Device Catalogue Number: CL-914
• Device Lot Number: A5B1689Y
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 02/26/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female