BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1834536 · Received September 9, 2010

    Report

    Report Number
    2024168-2010-01888
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 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: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. 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, HEAVILY CALCIFIED AND 99% 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 DURING INTERACTIONS WITH OTHER DEVICES AND/OR THE TORTUOUS AND CALCIFIED LESION SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE HEAVILY, CALCIFIED, 99% STENOSED RIGHT CORONARY ARTERY LESION, THE VOYAGER NC RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THIS WAS CONFIRMED TO BE A PINHOLE RUPTURE. THE DEVICE WAS COMPLETELY AND EASILY REMOVED FROM THE BODY AND ANOTHER VOYAGER WAS USED TO COMPLETE DILATATION. THERE WAS NO ADVERSE PT EFFECT. NO ADDITIONAL EVENT OR PT INFO WAS PROVIDED, THOUGH REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0052561

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BMW| GUIDE CATH: TAIGA JR4