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

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  

Event Description

It was reported that a 3.0 mm 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 pt 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 pt was taken back to surgery.The surgeon removed the flow-coupler doppler probe from the pt 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.Pt outcome is good.Mfr #2032282-2015-00019.

• Brand Name: FLOWCOUPLER, 3.0 MM
• Type of Device: ANASTOMOTIC COUPLER AND FLOW METER/MVR
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; st. paul MN
• MDR Report Key: 5200544
• MDR Text Key: 30502035
• Report Number: 5200544
• Device Sequence Number: 1
• Product Code: MVR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2015,09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• 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: 5151003000010
• Device Lot Number: SPSGT14-12L0008
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Distributor Facility Aware Date: 09/02/2015
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1