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

Model Number	8886612421
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Tissue Breakdown (2681); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a right ureteral reimplantation procedure, when the surgeon used the suture to fix the end of the ureter to the side wall of the left ureter, the suture needle broke and 2/3 of it was buried in the tissue, invisible to the naked eye.Under c-arm machine fluoroscopy, the stump of the suture needle was visible in the lower left abdomen.An electric hook was used to incise the side wall of the local bladder to search for the stump of the suture needle layer by layer, but the attempt failed.The search continued after the ureteral reimplantation was completed.Laparoscopy was used to search in the abdominal cavity.At the same time, the c-arm machine searched again, but still failed.A laparotomy was performed to explore.The patient's vital signs were unstable, and the surgeon, anesthesiologist, surgery center, and medical education department jointly decided to close the abdomen.The surgical time was extended due to the device problem.Five days after the procedure, the broken needle was removed by surgery.
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.

• Brand Name: MAXON CV
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19385653
• Report Number: 9612501-2024-01270
• Device Sequence Number: 17910518
• Product Code: GAM
• UDI-Device Identifier: 10884523002072
• UDI-Public: 10884523002072
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• 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): 05/23/2024

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 Expiration Date: 08/31/2025
• Device Model Number: 8886612421
• Device Catalogue Number: 8886612421
• Device Lot Number: D0J0425Y
• 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: 04/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Date Device Manufactured: 09/03/2020
• 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: Required Intervention
• Patient Sex: Male