BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX OVER-THE-WIRE

    MDR report key: 2110063 · Received June 1, 2011

    Report

    Report Number
    2134265-2011-01928
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED APEX BALLOON CATHETER REVEALED THE BALLOON WAS RETURNED IN A DEFLATED STATE. THE CATHETER WAS SOAKED IN A BATH OF CIRCULATING 37 DEGREE CELCIUS WATER FOR 24 HOURS TO ATTEMPT TO LOOSEN SOLIDIFIED CONTRAST IN THE BALLOON AND INFLATION LUMEN. EVEN AFTER SOAKING THE DEVICE IT COULD NOT BE INFLATED WITH AN INFLATION DEVICE FILLED WITH WATER. THE INNER AND OUTER SHAFT WAS FLAT/CRUSHED 64CM AND 100CM FROM THE EDGE OF THE STRAIN RELIEF. MICROSCOPIC INSPECTION REVEALED NO EVIDENCE OF ANY STRETCHING OR NECKING OF THE OUTER SHAFT THAT COULD CONTRIBUTE TO DEFLATION DIFFICULTY. A GUIDEWIRE WAS BACKLOADED INTO THE TIP AND TRACKED THROUGH THE LUMEN. THERE WAS RESISTANCE TRACKING AT THE LOCATIONS OF THE SHAFT DAMAGE. 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

    DEVICE EVALUATED BY MANUFACTURER: 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 PROCEDURE BALLOON DEFLATION ISSUES OCCURRED. THE ECCENTRIC DENOVO LESION WAS 8MM IN LENGTH, 2.0MM IN DIAMETER AND WAS LOCATED IN THE NON TORTUOUS AND MILDLY CALCIFIED 80-90% STENOSED DISTAL RIGHT CORONARY ARTERY (RCA). THE 12MM X 2.00MM APEX OTW BALLOON CATHETER WAS ADVANCED TO PRE DILATE THE TARGET LESION. THE BALLOON WAS INFLATED TO 12 ATMS FOR 10 SECONDS WITH RESIDUAL STENOSIS OF 0 -10%. A SLOW DEFLATION OCCURRED. NEGATIVE PRESSURE WAS APPLIED TO THE NON BSC INFLATION DEVICE AND THEN A SYRINGE WAS ATTACHED TO THE HUB AND DRAWN BACK TO SLOWLY DEFLATE THE BALLOON. THREE ION STENTS WERE THEN PLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE BALLOON DEFLATION ISSUES OCCURRED. THE ECCENTRIC DENOVO LESION WAS 8MM IN LENGTH, 2.0MM IN DIAMETER AND WAS LOCATED IN THE NON TORTUOUS AND MILDLY CALCIFIED 80-90% STENOSED DISTAL RIGHT CORONARY ARTERY (RCA). THE 12MM X 2.00MM APEX OTW BALLOON CATHETER WAS ADVANCED TO PRE DILATE THE TARGET LESION. THE BALLOON WAS INFLATED TO 12 ATMS FOR 10 SECONDS WITH RESIDUAL STENOSIS OF 0 -10%. A SLOW DEFLATION OCCURRED. NEGATIVE PRESSURE WAS APPLIED TO THE NON BSC INFLATION DEVICE AND THEN A SYRINGE WAS ATTACHED TO THE HUB AND DRAWN BACK TO SLOWLY DEFLATE THE BALLOON. THREE ION STENTS WERE THEN PLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX OVER-THE-WIRE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895812200 14175569

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INFLATION DEVICE, MERIT| GUIDE CATHETER, 6F JR4 LAUNCHER| GUIDE WIRE, HI TORQUE FLOPPY 300 CM