BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2063567 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02759
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE ADDITIONAL VOYAGER NC DEVICE IS BEING FILED UNDER SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH INFLATION OF THE BALLOON WITHIN THE BODY. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED FROM A PINHOLE IN THE BALLOON 1 MM PROXIMAL TO THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS CONCLUDED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. LONGITUDINAL LINES WERE FOUND AT AND NEAR THE LEAK ON THE OUTER SURFACE OF THE BALLOON. ADDITIONALLY, THE DISTAL MARKER EXHIBITED A RIDGE IN THE MATERIAL. THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE; HOWEVER, IT IS POSSIBLE THAT THE BALLOON AND MARKER WERE DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. IT WAS REPORTED THAT THE LESION WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY SIMILAR INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE FOLD AND DAMAGE NOTED CANNOT BE DETERMINED. BALLOON MATERIAL RUPTURE MAY BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. ALL DILATATION CATHETERS ARE 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 DURING POST DILATATION, AFTER STENT IMPLANTATION OF A MILDLY TORTUOUS, MODERATELY CALCIFIED, DE NOVO, MID LEFT ANTERIOR DESCENDING ARTERY, THE VOYAGER NC ((B)(4)) RUPTURED AT 4 ATMOSPHERE (ATM). A LEAK OF CONTRAST MEDIA WAS OBSERVED FROM THE BALLOON DURING THE PRESSURIZING. A SECOND VOYAGER NC ((B)(4)) WAS USED, HOWEVER, THE BALLOON RUPTURED AROUND 4 ATM AS WELL. IT WAS NOTED THAT 5 DIFFERENT BALLOON DILATATION CATHETERS, INCLUDING A THIRD VOYAGER NC WERE USED FOR POST STENT DILATATION TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0092761

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR XIENCE V STENT, ROTOBLATOR