MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD STEEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND

Model Number	88862414-89
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a coronary artery bypass grafting (cabg), blood was oozing out from surrounding when stitching the chest cavity from all 5 sutures.There was blood loss of more than 500cc due to the issue.The patient had to be re-operated with a different company's suture to resolve the issue.There was unanticipated tissue loss and tissue damage due to the issue.The patient hospitalization was extended 2 days.The surgical time was extended by 30 minutes or more due to the product problem.
Additional Manufacturer Narrative
D10 concomitant product: 88862414-89 steel 5 4x45cm kv40 rotogrip (lot#: d3e1424y); 88862414-89 steel 5 4x45cm kv40 rotogrip (lot#: d3e1424y); 88862414-89 steel 5 4x45cm kv40 rotogrip (lot#: d3e1424y); 88862414-89 steel 5 4x45cm kv40 rotogrip (lot#: d3e1424y).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.

• Brand Name: STEEL
• Common Device Name: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19147305
• Report Number: 9612501-2024-01011
• Device Sequence Number: 7406801
• Product Code: GAQ
• UDI-Device Identifier: 10884521102620
• UDI-Public: 10884521102620
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K955723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2024

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 Model Number: 88862414-89
• Device Catalogue Number: 88862414-89
• Device Lot Number: D3E1424Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Date Device Manufactured: 05/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Other; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male