MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number	VP-556-X
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during an open major vascular surgery, off-pump bypass, and vascular suturing procedure, four needles broke.An x-ray was performed to locate the needle, but it could not be found.The surgical time was extended to find the broken needles, delaying chest closure.A new suture was used to resolve the issue.The broke needle was not found and it was impossible to confirm whether the broken needle was outside the body or inside the body.
Additional Manufacturer Narrative
D10 concomitant product: vp-556-x surgipro ii 5-0 blu 90cm cv23da (lot#: d3g2572y); vp-556-x surgipro ii 5-0 blu 90cm cv23da (lot#: d3h3040y); vp-556-x surgipro ii 5-0 blu 90cm cv23da (lot#: d3h3039y) 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: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• 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: 19581293
• Report Number: 9612501-2024-01486
• Device Sequence Number: 3505871
• Product Code: GAW
• UDI-Device Identifier: 10884521037892
• UDI-Public: 10884521037892
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VP-556-X
• Device Catalogue Number: VP-556-X
• Device Lot Number: D3D0748Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/21/2024
• Date Device Manufactured: 04/10/2023
• 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
• Patient Sex: Unknown