BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1220841 · Received October 30, 2008

    Report

    Report Number
    2024168-2008-01025
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE IN THE. THE DISTAL END OF THE INNER AND OUTER MEMBER WERE NOT RETURNED. THE INNER MEMBER WAS DETACHED 2 MM DISTAL TO THE PROXIMAL BALLOON SEAL. THE OUTER MEMBER WAS DETACHED AT THE PROXIMAL BALLOON SEAL. THE FRACTURE FACES WERE JAGGED AT THE SEPARATIONS. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. THE PROTECTIVE SHEATH WAS NOT RETURNED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS RESULTS. IT WAS REPORTED THAT THE RX VOYAGER NC BALLOON SEPARATED FROM THE SHAFT DURING PREPARATION. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTIES REMOVING THE PROTECTIVE SHEATH INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING SUCH AS INADEQUATE BALLOON FOLDING, PROFILE CLEARANCE RATIO BETWEEN THE INNER DIAMETER OF THE PROTECTIVE SHEATH AND OUTER DIAMETER OF THE BALLOON, DAMAGE TO THE PROTECTIVE SHEATH, OR OVERSIZED BALLOON DUE TO PARTIAL INFLATION. THE BALLOON DETACHMENT WAS CONFIRMED, AS THE DISTAL END OF THE INNER MEMBER AND OUTER MEMBER WERE NOT RETURNED. THE INNER MEMBER WAS DETACHED DISTAL TO THE PROXIMAL BALLOON SEAL AND THE OUTER MEMBER WAS DETACHED AT THE PROXIMAL BALLOON SEAL. THE FRACTURE FACES WERE JAGGED AT THE SEPARATION, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD BEYOND ITS DESIGN LIMITS. THE PROTECTIVE SHEATH WAS NOT RETURNED, WHICH COULD HAVE AIDED IN THE INVESTIGATION. A FIELD DISCREPANCY NOTICE (FDN) WAS RECENTLY INITIATED ON 10/10/2008, FOR THE RX VOYAGER NC TO INVESTIGATE EXPERIENCED RESISTANCE WITH THE PROTECTIVE SHEATH AND HOW THE MANUFACTURING PROCESS MAY CONTRIBUTE TO THESE DIFFICULTIES. SINCE THE DEVICE FROM THIS INCIDENT EXHIBITED A SIMILAR FAILURE MECHANISM, THIS INCIDENT WILL BE INCLUDED IN THE FDN. ALL FURTHER INVESTIGATION AND CORRECTIVE ACTIONS WILL BE DOCUMENTED AND TRACKED IN THE FDN. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT WAS REVIEWED AND THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON SEPARATION HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: BALLOON SEPARATION. IT WAS REPORTED THAT THE BALLOON SEPARATED FROM THE SHAFT DURING PREPARATION. WHEN THE STYLE WAS REMOVED, RESISTANCE WAS FELT WHEN REMOVING THE SHEATH. THE CATHETER WILL BE RETURNED; HOWEVER, THE BALLOON AND STYLET HAVE BEEN MISPLACED. NO PT EFFECTS ERE REPORTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8050961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK