BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3822441 · Received May 20, 2014

    Report

    Report Number
    2134265-2014-02729
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.   (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN AND BALLOON AND BLOOD IN THE GUIDE WIRE LUMEN. THE BALLOON WAS LOOSELY FOLDED. THERE WERE NUMEROUS KINKS THROUGHOUT THE HYPOTUBE OF THE DEVICE. THE DISTAL TIP WAS DAMAGED. FUNCTIONAL TESTING WAS PERFORMED BY ATTACHING AN INFLATION DEVICE FILLED WITH WATER TO THE DEVICE. WHEN POSITIVE PRESSURE WAS APPLIED, A STREAM OF WATER EMITTED FROM THE BALLOON WALL. THE BALLOON WAS MICROSCOPICALLY EXAMINED AND A PINHOLE IN THE BALLOON WALL OVER THE PROXIMAL MARKER BAND WITH SCRATCHES WAS REVEALED. MICROSCOPIC EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. MICROSCOPIC EXAMINATION PRESENTED NO DAMAGE OR IRREGULARITIES IN THE BALLOON BONDS. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE REPORTED INFORMATION. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED UNSPECIFIED VESSEL. A 15MM X 2.50MM NC QUANTUM APEX BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. THE BALLOON RUPTURED AT 15 ATMOSPHERES. THE NUMBER OF INFLATIONS IS UNKNOWN. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED UNSPECIFIED VESSEL. A 15MM X 2.50MM NC QUANTUM APEX¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. THE BALLOON RUPTURED AT 15 ATMOSPHERES. THE NUMBER OF INFLATIONS IS UNKNOWN. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299609 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415250 15394042

    Patients

    Seq Age Sex Outcome Treatment
    1