BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1890990 · Received October 29, 2010

    Report

    Report Number
    2024168-2010-02288
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 4, 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)(6) EVALUATION SUMMARY: BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CHARACTERISTICS, PT 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 AND THE CATHETER WAS INITIALLY PRESSURIZED ONCE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS REPORTED AS MILDLY TORTUOUS, MILDLY CALCIFIED AND 85% 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. BASED ON THE INFO RECEIVED WITH THIS COMPLAINT, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT 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

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED WITH A 2.5 X 15 MM NON-ABBOTT BALLOON CATHETER. THEN, A NON-ABBOTT STENT WAS IMPLANTED. THEN, THE 3.5 X 08 MM VOYAGER NC WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED AT 6 ATMOSPHERES WHEN INFLATED FOR THE SECOND TIME. THUS, A 3.5 X 10 MM NON-ABBOTT BALLOON CATHETER WAS USED FOR FURTHER POST-DILATATION. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9120461

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: LIFESPEAR 2.5-15| GUIDE WIRE: RUNTHROUGHHYPERCOAT| VOYAGER NC 3.5-8| GUIDE WIRE: HEARTRAIL II JR3.5| STENT: ENDEAVOR 3.5-18| IBP 3.5-10