BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1859713 · Received October 1, 2010

    Report

    Report Number
    2024168-2010-02042
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). EVALUATION SUMMARY: A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED A LESION IN THE OSTIUM OF A SAPHENOUS VEIN GRAFT (SVG) IS DIRECT STENTED. A WAIST REMAINS IN THE STENT. A BALLOON IS POSITIONED AND INFLATED IN THE STENTED AREA AND THE WAIST IS RESOLVED. THE NEXT RUN SHOWS THAT THE BALLOON HAS BEEN REMOVED FROM THE ANATOMY. A SECOND STENT IS THEN DEPLOYED IN THE MID-SVG. THE REVIEWER CONCLUDED THAT UNFORTUNATELY THERE ARE NO IMAGES OF THE BALLOON OTHER THAN A SHORT RUN OF THE BALLOON IN AN INFLATED STATE. THUS, THE INCIDENT DESCRIPTION CANNOT BE CONFIRMED THROUGH CINE. THERE IS NOTHING IN THE IMAGES TO IDENTIFY THE REASON FOR THE INABILITY TO DEFLATE THE BALLOON. EVALUATION OF THE RETURNED VOYAGER NC DILATATION CATHETER NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE DISTAL SHAFT. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS LOOSELY FOLDED. THIS IS CONSISTENT WITH PREPARATION, THE CATHETER ADVANCED INTO THE PATIENT ANATOMY, AND THE BALLOON INFLATED. THE BALLOON CATHETER WAS RETURNED INSIDE A COMPETITOR'S GUIDING CATHETER AND IN A COMPETITOR'S ROTATING HEMOSTATIC VALVE (RHV). THE BALLOON WAS LOCATED AT THE DISTAL END OF THE GUIDING CATHETER. A BMW UNIVERSAL II GUIDE WIRE WAS RETURNED INSERTED IN THE GUIDE WIRE LUMEN OF THE VOYAGER NC. THE BALLOON CATHETER WAS ABLE TO BE REMOVED FROM THE GUIDING CATHETER AND RHV WITHOUT RESISTANCE. AN ATTEMPT WAS MADE TO REMOVE THE BMW GUIDE WIRE FROM THE CATHETER, BUT THE CORE SEPARATED 2.2 CM DISTAL TO THE CENTER SOLDER. THE SEPARATED PORTION REMAINED INSIDE THE GUIDE WIRE LUMEN OF THE CATHETER. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE OF THE CATHETER; WHICH WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS AND ADDITIONAL DAMAGE NOTED TO THE GUIDE WIRE 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 TO THE REPORTED DEFLATING THE BALLOON. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO DEFLATE A BALLOON CATHETER INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. THE TOTAL LENGTH OF THE CATHETER WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) WITH NO ANOMALIES NOTED. THE REPORTED DIFFICULTY DEFLATING THE BALLOON WAS UNABLE TO BE CONFIRMED AS THE DEFLATION TIMES OF THE BALLOON WERE MEASURED AND MET MANUFACTURING CRITERIA. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WHICH MAY HAVE AIDED IN THE EVALUATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE THAT THE ANATOMY NARROWED THE INFLATION LUMEN, CONTRIBUTING TO THE REPORTED DIFFICULTY TO DEFLATE; HOWEVER, THIS COULD NOT BE CONFIRMED. 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. RETURNED ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULTY DEFLATING THE BALLOON; THEREFORE A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER BALLOON INFLATION AND DEFLATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WITH A VOYAGER NC 4.5 X 12 THE BALLOON COULD NOT BE DEFLATED. THE BALLOON AND GUIDING CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9092462

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown Required Intervention