MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. VIRTUOSAPH, ENDOSCOPIC VEIN; VIRTUOSAPH DISPOSABLE

Model Number MCVS550

Device Problems Detachment Of Device Component (1104); Fracture (1260); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problems Discomfort (2330); Blood Loss (2597); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2015

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular systems corporation that during a full leg harvesting procedure, a 1/8" piece of the v-cutter tip broke off inside the patient's leg.A radiologist attempted to locate the missing piece using an ultrasound and fluoroscope but could not locate it.The attending physician determined that it would not be beneficial to further cut the patient to find the piece, so the detached material remains in the patient's leg.Additional information obtained from the user facility indicated that the procedure was conducted by a novice operator on a large patient who had poor tissue quality and diseased vein which caused the procedure to be difficult.The lower leg saphenous vein was harvested with all branches being cut in the usual manner.The trocar was used for lower and upper leg harvests and the incision was above the knee.The harvester was difficult to advance up the tunnel with the most difficulty being near the incision.Many adjustments were needed as well as rotation of the harvester tip to advance it forward.Resistance was felt and more effort than usual was needed to push the harvester up the tunnel.The harvester was finally advanced to the upper thigh, and when the vein was set up for cutting, the v-cutter was advanced to make contact with the active electrode.The operator then saw that the v-cutter had a missing section and did not proceed with cutting.The operator looked in the tunnel with the harvester to locate the missing piece but could not locate it.The device was changed out and the procedure was completed successfully.Since the harvested vein had sections that were not usable, the other leg was decided on for more harvesting.A senior operator took over the procedure for the next leg using the changed out device.Due to the patient's poor tissue quality and difficult anatomy, it was decided to make incisions and use open harvest.This procedure was also completed successfully.The additional information indicated that there was less than 30cc blood loss which is the usual amount for this procedure.There was approximately 90 minute delay due to x-rays and repeat manual examinations to locate the detached material that could not be found so the incisions were closed per protocol.A copy of the user facility medwatch form 3500a, reporting number (b)(4), is attached.The user facility risk management department currently has possession of the device.

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, an investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.Product identifier - (b)(4).

• Brand Name: VIRTUOSAPH, ENDOSCOPIC VEIN
• Type of Device: VIRTUOSAPH DISPOSABLE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell, manager ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4741739
• MDR Text Key: 5822882
• Report Number: 1124841-2015-00107
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/09/2015,04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2017
• Device Model Number: MCVS550
• Device Lot Number: 4XK
• Other Device ID Number: (01)00699753018945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2015
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention