BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 4170655 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06149
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A COYOTE NC BALLOON CATHETER. THERE WAS BLOOD IN THE HUB, INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. 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 13MM PROXIMAL OF THE DISTAL MARKERBAND 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 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED FROM THE SAME SIDE OF THE TARGET LESION VIA ANTEROGRADE APPROACH. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0MMX30MMX142CM FG COYOTE NC OTW (NC QUANTUM APEX¿) BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. IT WAS NOTED THAT THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 4, 15MM UNSPECIFIED SMALL PERIPHERAL CUTTING BALLOON. 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. VASCULAR ACCESS WAS OBTAINED FROM THE SAME SIDE OF THE TARGET LESION VIA ANTEROGRADE APPROACH. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0MMX30MMX142CM FG COYOTE NC OTW (NC QUANTUM APEX¿) BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. IT WAS NOTED THAT THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 4, 15MM UNSPECIFIED SMALL PERIPHERAL CUTTING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651595 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H74939284403010 17024555

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CRUSIE AND OTHER| INTRODUCER SHEATH: DESTINATION 6F 45CM