MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS COUPLER; DEVICE,ANASTOMOTIC,MICROVASCULAR

Catalog Number 511100250010

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a surgeon and a surgical assistant coupled the patient¿s vein with a coupler device and the device did not go together as normal; the device was further described as ¿coupler anastomosis microvascular red vessel range 2.3-2.8mm single gem".As a result, the surgeon had to cut the vein to remove the coupler device.Another coupler was used to anastomose the vein.The issue was identified in the treatment room during an unspecified surgical procedure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Catalogue # 511100250010.Lot # sp19a22-1348900.The device was received for evaluation.The rings show signs of used dried blood and tissue.A visual inspection shows the pins from the coupler ring within the inner diameter of the opposing coupler and one pin was bent.Further inspection shows that the rings was misaligned which causes the coupler to miss the mating holes on the opposite ring.The reported problem was verified.The cause of the condition was not 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): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• MDR Report Key: 8759314
• MDR Text Key: 149997011
• Report Number: 1416980-2019-03596
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511100250010
• Device Lot Number: SP19A22-1348900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1