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

Catalog Number 511100300060

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the ring of 3.0mm coupler was misaligned.During an unspecified procedure, the "ring was not able to fully attach and failed to complete the anastomosis".There was no patient injury or medical intervention associated with this event.

Manufacturer Narrative

Correction made to e1: initial reporter city: (b)(6).Correction made to e1: initial reporter e-mail: (b)(6).H10: a device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.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 ; 2242702068
• MDR Report Key: 12599154
• MDR Text Key: 275443590
• Report Number: 1416980-2021-06160
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): Y
• Reporter Country Code: TW
• 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
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 511100300060
• Device Lot Number: SP20H21-1471761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/15/2021
• 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