MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CAPROSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	SC-643
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products sc-643 sc-643 caprosyn* 3-0 und 75cm sc2 x36 d4a3964y sc-643 sc-643 caprosyn* 3-0 und 75cm sc2 x36 d4a3964y sc-643 sc-643 caprosyn* 3-0 und 75cm sc2 x36 d4a3964y sc-643 sc-643 caprosyn* 3-0 und 75cm sc2 x36 d4a3964y 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
It was reported that during a pacemaker insertion procedure, with an event in which one of five sutures was found to have the needle detached prior to removing it from the package upon opening.It was further reported that the next four sutures detached from the needle while being used, the break occurred at the connection of the needle and thread, and that the suture line did not hold.The product was replaced.

• Brand Name: CAPROSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25215938
• Report Number: 9612501-2026-01402
• Device Sequence Number: 10001176
• Product Code: GAM
• UDI-Device Identifier: 10884521034969
• UDI-Public: (01)10884521034969(17)261231(10)D4A3964Y
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K032586
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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 Model Number: SC-643
• Device Catalogue Number: SC-643
• Device Lot Number: D4A3964Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 01/24/2024
• 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