BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 890033 · Received September 28, 2006

    Report

    Report Number
    6000078-2006-00472
    Event Type
    Malfunction
    Date Received
    September 28, 2006
    Date of Event
    September 14, 2006
    Report Date
    September 15, 2006
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    MAF
    PMA / PMN Number
    H020002/S4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K): H020002/S5. THE DEVICE IN QUESTION HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED, HE WAS PERFORMING A STENTING AND COILING OF A WIDE NECK ANEURYSM. THE PHYSICIAN REPORTEDLY USED A PRIMARY ACCESS TECHNIQUE WITH AN ACCESS LENGTH SOFT-TIP GUIDE WIRE WHICH WAS INCLUDED AS A PART OF THE INTRAVASCULAR STENTING SYSTEM. THE WIRE WAS LOADED THROUGH THE HUB OF THE STENT DELIVERY CATHETER WHICH WAS CONTRARY TO DIRECTIONS FOR USE (DFU) THAT CALL FOR BACK-LOADING OF THE WIRE THROUGH THE OPPOSITE END OF THE DELIVERY CATHETER. EVEN THOUGH THE STENT WAS REPORTEDLY LOADED THROUGH THE OPPOSITE END, THERE WAS NO ISSUE WITH LOADING THE GUIDE WIRE. THE PHYSICIAN REPORTED WHEN THE STENT WAS POSITIONED, THEY TRIED TO MOVE THE STABLIZER FORWARD TO PUSH THE STENT TOWARDS THE CATHETER TIP IN PREPARATION FOR DEPLOYMENT, BUT THERE WAS A GREAT DEAL OF RESISTANCE, AND THE STENT DID NOT MOVE AS IT SHOULD HAVE. THE PHYSICIAN REPORTED THEY PULLED THE STABILIZER BACK, AND THE STENT MOVED BACK WITH THE STABILIZER WHICH IS NOT SUPPOSED TO HAPPEN. AS A RESULT, THE SYSTEM WAS REMOVED FROM THE PT AND THEY TRIED TO PUSH THE STENT FORWARD, BUT IT STILL DIDN'T MOVE FREELY. THE SUBSTITUTED THE STENT FOR A NEW SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW SYSTEM. THE NEW SYSTEM HAD NO ISSUES. THERE WAS NO ALLEGATION OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM INTRAVASCULAR STENT MAF NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP SNF34520 7698725

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND SOFT TIP (LOT NUMBER UNK)