BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 2243485 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03805
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THERE WAS A COMPLETE SEPARATION OF THE SHAFT. THE SHAFT SEPARATION WAS 121CM FROM THE STRAIN RELIEF AND 23CM FROM THE TIP. THERE WAS A 3 CM TEAR BEGINNING .75CM FROM THE WIRE EXIT NOTCH. THERE WAS NO EVIDENCE THAT THE SEPARATION WAS ATTRIBUTABLE TO ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER ERROR AS THE DEVICE WAS USED IN A PERIPHERAL VESSEL, CONTRARY TO LABELED INDICATIONS. THE DIRECTIONS FOR USE STATE; "THE NC QUANTUM APEX OVER-THE-WIRE AND NC QUANTUM APEX MONORAIL PTCA DIATION CATHETERS ARE INDICATED FOR THE BALLOON CATHETER DILATATION OF THE STENOTIC PORTION OF THE NATIVE CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION." (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE 100% STENOSED AND TOTALLY OCCLUDED TARGET LESIONS BEING TREATED WERE LOCATED IN THE SUPERFICIAL FEMORAL AND ILIAC ARTERIES. A BENTSON GUIDE WIRE WAS ADVANCED AND FAILED TO CROSS THE LESION. TWO ADDITIONAL NON-BSC GUIDE WIRES WERE ADVANCED AND ALSO FAILED TO CROSS THE LESION. A V18 GUIDE WIRE WAS THEN ADVANCED AND WAS ABLE TO CROSS THE LESION. A NON-BSC GUIDE CATHETER WAS ADVANCED OVER THE WIRE AND REACHED THE LESION LOCATION. THE GUIDE WIRE WAS EXCHANGED FOR A MAILMAN GUIDE WIRE. THE GUIDE CATHETER WAS REMOVED AND A 5.00X20MM NC QUANTUM APEX BALLOON CATHETER BEING USED FOR PRE-DILATION WAS ADVANCED OVER THE WIRE. WHILE ADVANCING THE NC QUANTUM APEX BALLOON THE PHYSICAN FELT RESISTANCE IN THE PROXIMAL PART OF THE VESSEL AND DECIDED TO REMOVE THE DEVICE. WHILE ATTEMPTING TO REMOVE THE DEVICE THE BALLOON SHAFT SEPARATED AND APPROXIMATELY 11CM OF THE DISTAL PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE GUIDE WIRE IN USE WAS REMOVED INTACT. THE PHYSICIAN DID NOT ATTEMPT TO SNARE THE DEVICE AND DECIDED TO BRING THE PATIENT BACK THE FOLLOWING DAY TO PERFORM A FEMORAL POPLITEAL BYPASS. THE BYPASS SURGERY WAS SUCCESSFULLY COMPLETED THE FOLLOWING DAY AND THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED PORTION OF THE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE A SHAFT BREAK OCCURRED. THE 100% STENOSED AND TOTALLY OCCLUDED TARGET LESIONS BEING TREATED WERE LOCATED IN THE SUPERFICIAL FEMORAL AND ILIAC ARTERIES. A BENTSON GUIDE WIRE WAS ADVANCED AND FAILED TO CROSS THE LESION. TWO ADDITIONAL NON-BSC GUIDE WIRES WERE ADVANCED AND ALSO FAILED TO CROSS THE LESION. A V18 GUIDE WIRE WAS THEN ADVANCED AND WAS ABLE TO CROSS THE LESION. A NON-BSC GUIDE CATHETER WAS ADVANCED OVER THE WIRE AND REACHED THE LESION LOCATION. THE GUIDE WIRE WAS EXCHANGED FOR A MAILMAN GUIDE WIRE. THE GUIDE CATHETER WAS REMOVED AND A 5.00X20MM NC QUANTUM APEX BALLOON CATHETER BEING USED FOR PRE-DILATION WAS ADVANCED OVER THE WIRE. WHILE ADVANCING THE NC QUANTUM APEX BALLOON THE PHYSICIAN FELT RESISTANCE IN THE PROXIMAL PART OF THE VESSEL AND DECIDED TO REMOVE THE DEVICE. WHILE ATTEMPTING TO REMOVE THE DEVICE THE BALLOON SHAFT SEPARATED AND APPROXIMATELY 11CM OF THE DISTAL PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE GUIDE WIRE IN USE WAS REMOVED INTACT. THE PHYSICIAN DID NOT ATTEMPT TO SNARE THE DEVICE AND DECIDED TO BRING THE PATIENT BACK THE FOLLOWING DAY TO PERFORM A FEMORAL POPLITEAL BYPASS. THE BYPASS SURGERY WAS SUCCESSFULLY COMPLETED THE FOLLOWING DAY AND THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED PORTION OF THE DEVICE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 H7493912420500 14010057

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention TERUMO GLIDEWIRE GUIDE WIRE| 0.014" MAILMAN GUIDE WIRE| TERUMO GLIDE CATHETER GUIDE CATHETER| BENTSON GUIDE WIRE| V18 CONTROL GUIDE WIRE