BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1831798 · Received September 8, 2010

    Report

    Report Number
    2024168-2010-01879
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AND INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS REPORTED AS MODERATELY TORTUOUS AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. THE BALLOON MATERIAL MAY HAVE BEEN DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, THE IMPLANTED STENT AND/OR THE TORTUOUS LESION SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED. ULTIMATELY, RETURN OF THE VOYAGER NC MAY HAVE AIDED THE EVALUATION IN DETERMINING A CAUSE FOR THE EXPERIENCED RUPTURE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. IN THIS INSTANCE, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED, HOWEVER, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EFFECT: NONE. IT WAS REPORTED THAT DURING POST-DILATATION OF A NON-ABBOTT STENT IN THE PROXIMAL RIGHT CORONARY ARTERY, THE VOYAGER NC BALLOON RUPTURED AT 12 ATMOSPHERES DURING THE FIRST INFLATION. POST-DILATATION WAS COMPLETED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9111061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: HEAT RAIL II JR3.5| GUIDE WIRE: RUNTHROUGH HC| STENT: LIBERTE 4.0-16