BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2171889 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05083
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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. GUIDE WIRE: RUNTHROUGH. GUIDE CATH: JR4 CORDIS 6F. SHEATH: 6F. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED VOYAGER NC NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, THE INFLATION LUMEN AND IN THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) AND THE ANALYSIS CONFIRMED THAT THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON LOCATED 0.5 MM PROXIMAL TO THE DISTAL BALLOON MARKER, EXTENDING PROXIMALLY FOR A LENGTH OF 6 MM. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO: BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO EXPOSURE CONDITIONS AND/OR A MATERIAL PROCESSING DISCREPANCY. THERE WERE MULTIPLE PARTIAL TEARS OBSERVED ALONG THE INNER SURFACE OF THE BALLOON AT THE RUPTURE EDGE. MECHANICAL DAMAGE TO THE OUTER SURFACE WAS ALSO NOTED. DAMAGE OF THIS TYPE IS ALSO CONSISTENT WITH MULTIPLE INFLATIONS AND/OR HIGH STRESS BEING APPLIED TO THE BALLOON MATERIAL. AS 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 MILDLY CALCIFIED AND MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. IT WAS FURTHER NOTED THAT THE BALLOON WAS PRESSURIZED ABOVE THE LABELED RBP TO 22 ATMOSPHERES. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE WARNS: BALLOON PRESSURE SHOULD NOT EXCEED THE RBP. USE A PRESSURE-MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. INFLATING THE BALLOON CATHETER BEYOND ITS SPECIFIED RBP LIKELY CONTRIBUTED TO THE EXPERIENCED RUPTURE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY THE RBP AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING FOR BALLOON INTEGRITY TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS RECEIVED:THE BALLOON RUPTURE OCCURRED AT 22 ATMOSPHERES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF THE VOYAGER NC CATHETER RUPTURED DURING INFLATION IN THE MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 0092262

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR