BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1842305 · Received August 27, 2010

    Report

    Report Number
    2024168-2010-01778
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 3, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED THAT WITH THE FIRST ATTEMPT TO PRESSURIZE THE BALLOON USING A NEW INDEFLATOR, THE BALLOON WOULD NOT INFLATE. AFTER THE CATHETER WAS SOAKED IN A WARM WATER BATH, THE BALLOON WAS THEN ABLE TO BE INFLATED; HOWEVER, FLUID WAS NOTED TO BE LEAKING FROM A PINHOLE IN THE MIDDLE OF THE BALLOON, CONFIRMING THE REPORTED RUPTURE. THERE WERE NO SCRATCHES VISIBLE. THE PRODUCT WAS SENT TO SCANNING ELECTRON MICROSCOPY FOR FURTHER ANALYSIS, WHICH DETERMINED THAT THE RUPTURE MAY POSSIBLY BE RELATED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL BALLOON CATHETERS ARE 100% LEAK TESTED ON LINE AND A SAMPLING OF UNITS ARE RUPTURE TESTED PRIOR TO RELEASE. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. THE PATIENT ANATOMY WAS NOT DESCRIBED IN THE CASE INFORMATION WHICH MAY HAVE AIDED IN THE EVALUATION. AN INTERACTION WITH OTHER DEVICES AND/OR THE LESION MAY HAVE DAMAGED (SCRATCHED) AND WEAKENED THE BALLOON MATERIAL, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT 9 ATM WHICH IS BELOW THE RATED BURST PRESSURE OF 18 ATM. ANALYSIS NOTED A BEND IN THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BEND MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED THE REPORTED BALLOON RUPTURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. NO CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE, AS A CONCLUSIVE CAUSE COULD NOT BE DETERMINED AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE VOYAGER NC RUPTURED AT 9 ATMOSPHERES (ATMS) DURING THE FIRST INFLATION IN THE RIGHT CORONARY ARTERY. VESSEL CHARACTERISTICS ARE UNKNOWN. THE VOYAGER NC WAS COMPLETELY REMOVED FROM THE PATIENT. ANOTHER VOYAGER NC OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9102161

    Patients

    Seq Age Sex Outcome Treatment
    1