MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	SL-694
Medical Device Problem Codes	Unraveled Material (1664); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, following a veterinary oophorectomy, there was dehiscence on the muscle wall wounds where the device was used.This caused disembowelments with emergency surgical revision.There was no trace of infection observed during revisions or elements of thread rejections.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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, a month after a veterinary ovariectomy, wherein the muscular belly walls were sutured with single stitches crossed, there was a soft mass under the wound as big as a golf ball.Echography showed discontinuation of the muscle pain.It was noted that the suture line did not hold, which resulted in wound dehiscence.Four days later, the patient was re-operated with withdrawal of the suture and re-suturing with polydioxanone suture.There was no trace of infection observed during revisions or elements of thread rejections.The patient was re-admitted to the hospital.
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.
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, a month after a veterinary ovariectomy, wherein the muscular belly walls were sutured with single stitches crossed, there was a soft mass under the wound as big as a golf ball.Two days after, there was a non-painful, non-inflammatory unresectable mass of five centimeter (cm) in diameter at the surgical wound.Echography showed discontinuation of the muscle pain.It was noted that the suture line did not hold, which resulted in wound dehiscence.Four days later, the patient was re-operated with withdrawal of the suture and re-suturing with polydioxanone suture.There was no trace of infection observed during revisions or elements of thread rejections.The patient was re-admitted to the hospital.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20272871
• Report Number: 9612501-2024-02428
• Device Sequence Number: 3505345
• Product Code: GAM
• UDI-Device Identifier: 10884521049253
• UDI-Public: 10884521049253
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2024

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 Model Number: SL-694
• Device Catalogue Number: SL-694
• Device Lot Number: A3D0646FY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 09/20/2024; 10/02/2024; 12/04/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/02/2024; 10/04/2024; 12/06/2024
• Date Device Manufactured: 04/26/2023
• 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 Age: 12 MO
• Patient Sex: Female
• Patient Weight: 3 KG