MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS FLOWCOUPLER,3.0MM; ANASTOMOTIC COUPLER AND FLOW METER

Model Number GEM2754-FC

Device Problem Failure to Sense (1559)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record for this lot number was reviewed.100% visual inspection for broken or missing parts and pin alignment is performed on each assembly during the manufacturing process.The ring separation force and the ring retention force is within specification.The doppler probes are inspected 100% for visual defects and tested 100% for functionality.According to the device history record, the device met specification prior to market release.The flow-coupler doppler probe wire was cut by the surgeon when the patient was taken back into surgery.The doppler probe was discarded and a portion of the probe wire was returned to synovis for evaluation.The external lead wire was also returned for evaluation.There were no marks that would indicate damage to probe wire.There was no functional testing performed with the returned portion of the probe wire.The external lead wire was tested and found to be functioning as intended.With the probe wire cut by the surgeon and the doppler probe discarded, a full investigation cannot be completed and root cause of the lost signal cannot be determined.

Event Description

It was reported that a 3.0mm gem microvascular anastomotic flow-coupler was implanted during a free alt flap from thigh to neck (pharynx) procedure.The flow-coupler was placed on the flap vein (descending lateral femoral circumflex vein) to branch of internal jugular vein in the left neck.The patient was taken to the icu and the physician confirmed good venous flow via flow-coupler doppler signal.Two days post-op the physician noted a loss of flow-coupler doppler signal.The patient was taken back to surgery.The surgeon removed the flow-coupler doppler probe from the patient and implanted a cook brand doppler cuff to monitor the buried pharyngeal flap.The coupled venous anastomosis was left intact.The flow-coupler rings remain implanted.Patient outcome is good.

• Brand Name: FLOWCOUPLER,3.0MM
• Type of Device: ANASTOMOTIC COUPLER AND FLOW METER
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: scott johnson ; 2575 university ave. w; saint paul, MN 55144 ; 6517967334
• MDR Report Key: 5114754
• MDR Text Key: 27259766
• Report Number: 2032282-2015-00019
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2016
• Device Model Number: GEM2754-FC
• Device Catalogue Number: 515100300010
• Device Lot Number: SPSGT14-12L0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2014
• 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
• Patient Age: 56 YR