MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION COUPLER DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number 511100300060

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the pin of 3. 0mm coupler - 6/bx was dislodged. During anastomosis, one pin was ¿hanging out of the anastomotic ring from the slot¿. The user reinserted ¿the anastomotic ring into slot, the pin still came out when the it was hung up again¿. This operation was repeated three times, but still could not complete the anastomosis. The couple was removed and checked. The ring was observed and ¿the slot was too loose¿. The coupler was replaced to complete the procedure. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

• Brand Name: COUPLER
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 11131670
• MDR Text Key: 225524608
• Report Number: 1416980-2020-08370
• Device Sequence Number: 1
• Product Code: MVR
• UDI-Device Identifier: 10844735002680
• UDI-Public: 10844735002680
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 511100300060
• Device Lot Number: SP20B27-1432057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial