BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX FLEX MONORAIL

    MDR report key: 1040391 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01321
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    March 3, 2008
    Report Date
    April 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS VERIFIED THE DIFFICULTY STATED IN THE COMPLAINT FOR SHAFT KINKED. THE RETURNED CATHETER EXHIBITED NUMEROUS KINKS ALONG THE HYPOTUBE AND WAS FOUND TO BE BROKEN 15.5 CM PROXIMAL OF THE HUB. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE HYPOTUBE FRACTURE AND KINKS DID NOT REVEAL ANY INHERENT DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE KINKS. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS PRIOR TO SHIPMENT. BASED ON THIS ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 04/30/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE SHAFT OF THE DEVICE WAS KINKED. THE LESION WAS LOCATED IN A 99% STENOSED UNSPECIFIED VESSEL. THE PHYSICIAN ADVANCED A NON-BSC BALLOON BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN CHANGED TO A 1.50 X 15 MM APEX FLEX MONORAIL BALLOON CATHETER, HOWEVER, DURING ADVANCEMENT TO THE LESION, THE SHAFT KINKED. THE DEVICE WAS CHANGED TO A 1.5 X 8 MM APEX PUSH BALLOON CATHETER BUT THE SHAFT KINKED WHEN THE BALLOON CROSSED THE LESION. THE LESION WAS EVENTUALLY DILATED USING A 1.5 X 6 MM NON-BSC BALLOON AND A LIBERTE STENT, UNKNOWN SIZE, WAS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED THAT THE SHAFT WAS BROKEN 15.5 CM FROM THE HUB OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX FLEX MONORAIL NA LOX BOSTON SCIENTIFIC 1.50X15MM 11124215

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5X6MM SPRINTER BALLOON