MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM; NONE

Catalog Number MCVS550

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problems Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 04/08/2015

Event Type  Injury  

Event Description

The plastic piece of the end of the cautery piece of the evh system broke leaving about an 1/8" piece inside of the patient's leg.Dr.(b)(6) from radiology used ultrasound and fluoroscope to try and locate the piece of plastic.Dr.(b)(6) felt it would be more detrimental to the patient to filet the patient's leg open to look for the piece.Therefore, it was left in the patient.The terumo rep was notified.Risk mgmt has possession of the device.

• Brand Name: VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM
• Type of Device: NONE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM; p.o. box 281402; atlanta GA 30384
• MDR Report Key: 4741627
• MDR Text Key: 21541263
• Report Number: 4741627
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• 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

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: MCVS550
• Device Lot Number: 4XK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR