BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX COROANRY DILATATION CATHETER

    MDR report key: 1884901 · Received October 15, 2010

    Report

    Report Number
    2024168-2010-02176
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 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 CHARACTERISTICS, PATIENT DISEASE STATE, AN 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, MODERATELY 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. ULTIMATELY, RETURN OF THE VOYAGER MAY HAVE AIDED THE EVALUATION IN DETERMINING A CAUSE FOR THE RUPTURE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS IN A MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) WITH A 99% STENOSIS. THE VOYAGER NC WAS BEING USED FOR PRE-DILATATION; HOWEVER, THE BALLOON RUPTURED AT 8 ATMOSPHERES WHEN INFLATED FOR THE FIRST TIME. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX COROANRY DILATATION CATHETER LOX ABBOTT VASCULAR - CARDIAC THERAPIES NA 9070763

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: XIENCE V| GUIDE WIRE: RUNTHROUGH| GUIDING CATHETER: ACCESS| DILATATION CATHETER: VOYAGER