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

Catalog Number 511100200060

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

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 a 2.0mm coupler had misaligned rings.This was discovered during intraoperative procedure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the devices were received for evaluation.Signs of use (dried blood and tissue) were visible on the returned coupler rings.A visual inspection was done which observed a misalignment in the rings.The misalignment visible in the returned rings would not allow for the process to be completed successfully with the rings in the orientation in which they were brought together (approximated).The reported condition was verified.The cause of the condition could not be determined; however, if either of the two coupler rings were inadvertently nudged or moved within the jaw assembly during removal of the white plastic holder, in preparation for use or during the surgical process, it is possible that one of the coupler rings could have become misaligned.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 16621873
• MDR Text Key: 312130639
• Report Number: 1416980-2023-01356
• Device Sequence Number: 1
• Product Code: MVR
• UDI-Device Identifier: 10844735002642
• UDI-Public: 10844735002642
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511100200060
• Device Lot Number: SP21H10-1561540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.