PERFUSION SYSTEMS DLP MALLEABLE SINGLE STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
|
Back to Search Results |
|
Model Number 68128 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 11/13/2023 |
Event Type
Injury
|
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.
|
|
Event Description
|
Medtronic received information that after the use of a dlp malleable single stage venous cannula, it was reported that during the replacement of the arch and an open stent, the sternal closure wire of the infected patient was extracted and the wound was re-sutured, but the infection continued.The infection occurred around the surgical steel wire, and it was removed and sutured again, but the infection wound did not heal, and a ct scan showed a seroma like mass under the suture site. the relationship between the reported event and the use of medtronic product is unknown.Medtronic received additional information that the surgical steel wire was a non-medtronic product.The cannula used during the case was a dlp cannula.The customer stated that the relationship between the infection and the medtronic product is unknown.
|
|
Search Alerts/Recalls
|
|
|