BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM? MAVERICK?

    MDR report key: 3203076 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04673
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE QUANTUM MAVERICK CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS A COMPLETE SEPARATION OF THE HYPOTUBE. THE HYPOTUBE SEPARATION WAS 27CM FROM THE HYPOTUBE/MID-SHAFT BOND. THE HYPOTUBE FRACTURE SURFACES WERE OVALED, WHICH SUGGESTS THE DEVICE WAS KINKED PRIOR TO SEPARATION. 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 OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CATHETER SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING DEPLOYMENT OF UNSPECIFIED STENTS, THE PHYSICIAN ADVANCED A 3.75MM X 15MM QUANTUM¿ MAVERICK¿ BALLOON CATHETER TO POST DILATE THE TREATED LESION. WHILE PUSHING THE DEVICE, THE CATHETER SHAFT BROKE AT ABOUT 80CM AWAY FROM THE HUB. THE DEVICE WAS WITHDRAWN WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.75*15MM QUANTUM MAVERICK BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, CATHETER SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MILDLY CALCIFIED AND NON-TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING DEPLOYMENT OF UNSPECIFIED STENTS, THE PHYSICIAN ADVANCED A 3.75MM X 15MM QUANTUM MAVERICK BALLOON CATHETER TO POST DILATE THE TREATED LESION. WHILE PUSHING THE DEVICE, THE CATHETER SHAFT BROKE AT ABOUT 80CM AWAY FROM THE HUB. THE DEVICE WAS WITHDRAWN WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.75 X 15MM QUANTUM MAVERICK BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301244 QUANTUM? MAVERICK? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493808015370 15783950

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR