BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2180460 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03304
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: MIROSCOPIC INSPECTION REVEALED THAT A 3CM LENGTH OF THE INNER SHAFT WAS BUCKLE. THE DAMAGE EXTENDED ON BOTH SIDES OF THE PROXIMAL BALLOON BOND. MEASUREMENTS OF THE INNER DIAMETER OF THE WIRE LUMEN AT THE DISTAL TIP AND THE WIRE EXIT NOTCH MEET SPECIFICATIONS. A .014" GUIDE WIRE WAS BACK-LOADED INTO THE TIP OF THE CATHETER AND TRACKED THROUGH THE LUMEN; HOWEVER, THE WIRE WOULD NOT ADVANCE PAST THE LOCATION OF THE BUCKLED INNER SHAFT. A THOROUGH INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITIES. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, THE CATHETER STUCK TO THE WIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN PERFORMED IVUS USING A NON-BSC GUIDE WIRE WITHOUT ANY ISSUES. THEN THE PHYSICIAN ADVANCED THE 2.75X15MM NC QUANTUM APEX BALLOON OVER THE NON-BSC GUIDE WIRE TO PREDILATE THE LESION, BUT IT WAS REALLY STICKY AND THE CATHETER STUCK ON THE WIRE. AFTER COMPLETING PREDILATION WITH THIS DEVICE, THE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER AS ONE UNIT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, THE CATHETER STUCK TO THE WIRE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN PERFORMED IVUS USING A NON-BSC GUIDE WIRE WITHOUT ANY ISSUES. THEN THE PHYSICIAN ADVANCED THE 2.75X15MM NC QUANTUM APEX BALLOON OVER THE NON-BSC GUIDE WIRE TO PREDILATE THE LESION, BUT IT WAS REALLY STICKY AND THE CATHETER STUCK ON THE WIRE. AFTER COMPLETING PREDILATION WITH THIS DEVICE, THE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER AS ONE UNIT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415270 14253321

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR RUN THROUGH GUIDE WIRE| VOLCANO DIAGNOSTIC CATHETER| BMW GUIDE WIRE