BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME? CUTTING BALLOON?

    MDR report key: 4152801 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-05910
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: INSPECTION OF THE RETURNED DEVICE REVEALED A JR50 .071 SHEATH AND 0.014" GUIDEWIRE WERE ALSO RETURNED AND THAT THE COMPLAINT DEVICE WAS RETURNED INSERTED THROUGH THE SHEATH, OVER THE GUIDEWIRE. THE BALLOON WAS POSITIONED DISTAL TO THE SHEATH TIP. THE CATHETER MOVED FREELY ON THE GUIDEWIRE AND THE CATHETER MOVED FREELY WITHIN THE SHEATH ALSO. THE MIDSHAFT OF THE FLEXTOME CATHETER WAS ELONGATED ALONG ITS LENGTH WHICH IS A RESULT OF APPLIED TENSILE FORCE USED DURING THE REPORTED ATTEMPTS TO REMOVE THE CATHETER FROM THE SHEATH. CATHETER SHAFT: A VISUAL AND TACTILE EXAMINATION WAS PERFORMED WHICH CONFIRMED A SHAFT KINK AT THE STRAIN RELIEF AREA OF THE CATHETER JUST DISTAL TO THE HUB. IN AN ATTEMPT TO INFLATE AND DEFLATE THE BALLOON FOR REMOVAL OF THE CATHETER THROUGH THE SHEATH, THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT. POSITIVE PRESSURE WAS APPLIED WHEN A SIGNIFICANT LEAK WAS NOTED AT THE HUB. A MICROSCOPIC EXAMINATION CONFIRMED THE HUB WAS CRACKED THROUGHOUT. IT IS DETERMINED THAT THIS CRACK OCCURRED AS A RESULT OF EXCESSIVE MANIPULATION/HANDLING AFTER THE PROCEDURE AS IT WAS CONFIRMED THAT THIS BALLOON WAS INFLATED TO 12 ATMOSPHERES FOR 30 SECONDS. THERE WAS NO REPORTED LEAK. A MICROSCOPIC EXAMINATION CONFIRMED NO DAMAGE TO THE TIP, BALLOON, OR BLADES. AS THE BALLOON COULD NOT BE INFLATED/DEFLATED, THE CATHETER WAS PULLED PROXIMALLY THROUGH THE SHEATH IN ITS CURRENT STATE AND NO RESISTANCE WAS NOTED. ALTHOUGH IT WAS NOT POSSIBLE TO APPLY A VACUUM TO THE BALLOON, THE BALLOON WAS REMOVED FROM THE SHEATH WITH NO RESISTANCE ENCOUNTERED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN PUSHED A 4.0X15 MM FLEXTOME CUTTING BALLOON THROUGH A NON-BSC 6F JR5 GUIDE CATHETER OVER A NON-BSC GUIDEWIRE. THE PHYSICIAN FELT A STRONG RESISTANCE AND THE DEVICE WAS NOT ABLE TO CROSS THE LESION. THE PHYSICIAN CHANGED TO A 3.5MM NON-CONFORMING (NC) BALLOON TO CROSS THE LESION. THE FLEXTOME CUTTING BALLOON WAS REINTRODUCED AND THE LESION WAS DILATATED TWICE FOR 30 SECONDS AT 12 ATM. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE FLEXTOME CUTTING BALLOON HE FELT A VERY STRONG RESISTANCE AND IT WAS NOT POSSIBLE TO GET THE DEVICE INTO THE GUIDE CATHETER AGAIN. THE PHYSICIAN REMOVED ALL DEVICES TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. DURING THE WHOLE PROCEDURE THERE WAS NO IMPACT TO THE PATIENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN PUSHED A 4.0X15 MM FLEXTOME¿ CUTTING BALLOON¿ THROUGH A NON-BSC 6F JR5 GUIDE CATHETER OVER A NON-BSC GUIDEWIRE. THE PHYSICIAN FELT A STRONG RESISTANCE AND THE DEVICE WAS NOT ABLE TO CROSS THE LESION. THE PHYSICIAN CHANGED TO A 3.5MM NON-CONFORMING (NC) BALLOON TO CROSS THE LESION. THE FLEXTOME¿ CUTTING BALLOON¿ WAS REINTRODUCED AND THE LESION WAS DILATATED TWICE FOR 30 SECONDS AT 12 ATM. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE FLEXTOME¿ CUTTING BALLOON¿ HE FELT A VERY STRONG RESISTANCE AND IT WAS NOT POSSIBLE TO GET THE DEVICE INTO THE GUIDE CATHETER AGAIN. THE PHYSICIAN REMOVED ALL DEVICES TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. DURING THE WHOLE PROCEDURE THERE WAS NO IMPACT TO THE PATIENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630766 FLEXTOME? CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4400150 16868211

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR BMW GUIDEWIRE| LAUNCHER 6F JR5 GUIDE CATHETER