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

Catalog Number 511100200060

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent a diep (deep inferior epigastric perforator) surgery in which a 2.0 flow coupler was used.During the surgery, the surgeon had pulled the vein through the device and ¿tacked down on coupler sides¿.Once ready to close the device, one side of the coupler slid off the black plastic piece without the device being closed.A second coupler was used, and the event occurred again when attempting to implant.It was reported a vein shortening and manipulation were performed.It was reported successful anastomosis was completed without any issues noted.No additional information is available.

Manufacturer Narrative

Two actual devices and two companion sample were received for evaluation.Sample analysis and visual inspection were performed.The first actual sample showed signs of use (dried blood/tissue) and showed the rings to be approximated in a misaligned manner.A slight slipping of the rings in the jaws would lead to a misalignment during approximation of not noticed before the approximation began.With the approximation of the rings on this returned product, it is inconsistent with the reported event statement that the ring completely dislodged from the jaw assembly.The second actual sample was returned with the left ring missing from the jaw assembly which is consistent with the complainant¿s statement that the ring dislodged from the jaw assembly.The reported condition was verified.The two companion samples were tested for ring retention.The left side ring retention force was tested on both samples.The results of the ring retention testing show that the functional specification requirement was met.The reported condition was not verified.A device history review revealed no issues that could have caused or contributed to the reported issue.The cause of the condition could not be determined.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
• MDR Report Key: 10453839
• MDR Text Key: 204364324
• Report Number: 1416980-2020-05188
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): Y
• PMA/PMN Number: K861985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511100200060
• Device Lot Number: SP20B28-1432643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR