|
Model Number SM-5627 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/03/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
D10 concomitant product: sm-5627 biosyn* 4-0 und 45cm p12 x12 (lot#: d4a2912fy) 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 Description
|
According to the reporter, during an open revision arteriovenous (av) fistula procedure, the surgeon used three of the 4-0 sutures, and with two of the sutures, the needle came off the suture (not pop-offs).A new suture was used to resolve the issue.There was no patient injury.
|
|
Search Alerts/Recalls
|
|
|