MAUDE Adverse Event Report: SYNOVIS MICRO COMPANIES ALLIANCE, INC; DEVICE, ANASTOMOTIC, MICROVASCULAR

Model Number GEM2756FC

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2020

Event Type  malfunction  

Event Description

Attempted removal of flow coupler wire; could not see doppler probe at end of wire, concern as to whether some wire could be left in situ.Patient sent for neck x-ray.In the meantime, communicated with synovis, who advised that if the wire can be removed without invasive procedure, they recommend removing the remaining wire.However, they advised that many surgeons simply cut the wire at the skin and leave the internal portion of the wire in situ.X-ray showed some retained wire.Spoke with the patient.Advised that wire is easy to access and superficial, and that by opening a couple of sutures the wire could be removed and the area closed back up.Advised that the company recommends removal if it is easy to do, and that considering it would only require a couple of stitches the recommendation was to remove it.The patient elected for removal.Using sterile technique, the neck was prepped.The area was anesthetized.A couple of sutures were removed.The wire was easily visualized.It was grasped with a needle driver.Gentle tension was applied, and it released from the coupler.The end was examined and the doppler was visible at the removed end, showing that the complete wire had been removed.The coupler was visualized in the neck and the wire had been fully removed.There was no bleeding.The sutures were replaced.Manufacturer response for flow coupler 4.0mm w/ doppler, (brand not provided) (per site reporter): communicated with synovis, who advised that if the wire can be removed without invasive procedure, they recommend removing the remaining wire.However, they advised that many surgeons simply cut the wire at the skin and leave the internal portion of the wire in situ.

Event Description

Attempted removal of flow coupler wire; could not see doppler probe at end of wire, concern as to whether some wire could be left in situ.Patient sent for neck x-ray.In the meantime, communicated with synovis, who advised that if the wire can be removed without invasive procedure, they recommend removing the remaining wire.However, they advised that many surgeons simply cut the wire at the skin and leave the internal portion of the wire in situ.X-ray showed some retained wire.Spoke with the patient.Advised that wire is easy to access and superficial, and that by opening a couple of sutures the wire could be removed and the area closed back up.Advised that the company recommends removal if it is easy to do, and that considering it would only require a couple of stitches the recommendation was to remove it.The patient elected for removal.Using sterile technique, the neck was prepped.The area was anesthetized.A couple of sutures were removed.The wire was easily visualized.It was grasped with a needle driver.Gentle tension was applied, and it released from the coupler.The end was examined and the doppler was visible at the removed end, showing that the complete wire had been removed.The coupler was visualized in the neck and the wire had been fully removed.There was no bleeding.The sutures were replaced.Manufacturer response for flow coupler 4.0mm w/ doppler, (brand not provided) (per site reporter).Communicated with synovis, who advised that if the wire can be removed without invasive procedure, they recommend removing the remaining wire.However, they advised that many surgeons simply cut the wire at the skin and leave the internal portion of the wire in situ.

• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): SYNOVIS MICRO COMPANIES ALLIANCE, INC; 439 industrial ln; birmingham AL 35211
• MDR Report Key: 10337709
• MDR Text Key: 200796436
• Report Number: 10337709
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GEM2756FC
• Device Lot Number: SP19F141379372
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 61