INVISIGRIP VEIN STRIPPER
Received Jun 30, 2011
Report 1220948-2011-00005 · MDR key 2185856
Device
Generic name
Invisigrip
Manufacturer
Lemaitre VascularModel number
1500-01Catalog number
1500-01
Lot number
IVS1080
Product problems
- Detachment Of Device Component
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Tissue Damage
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WERE ABLE TO VERIFY THE FAILURE. THE NOSEPIECE WAS SEPARATED FROM THE WIRE. THE GRIPPER BLADES WAS PULLED OUT FROM SPRINGWIRE (THE SPRINGWIRE AND GRIPPER BLADES ARE OVERMOLDED IN ONE OPERATION). THE ROOT CAUSE OF THE FAILURE IS INCONCLUSIVE. IT IS POSSIBLE THE EXCESSIVE FORCE AND/OR CALCIFIED VESSEL CONTRIBUTED TO THE FAILURE. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. WE HAVE NOT SEEN THIS TYPE OF COMPLAINT BEFORE. THEREFORE, IT WAS AN ISOLATED INCIDENT. WE MADE AWARE OUR SUPPLIER OF SUBASSEMBLIES OF THIS INCIDENT. PLEASE NOTE THAT THE PT IS FINE AND WAS NOT INJURED DURING THIS INCIDENT.
Description of Event or Problem
DURING THE PROCEDURE, THE PHYSICIAN PULL THE HANDLE OF THE DEVICE AFTER LOCKING THE VESSEL AT THE TIP OF THE NOSEPIECE. AT THIS MOMENT, THE NOSEPIECE SEPARATED FROM THE WIRE, AND LEFT IN THE VESSEL. THE PHYSICIAN CUT THE VESSEL AND REMOVED THE PIECE OUT OF IT. PT IS FINE.