BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX? PUSH

    MDR report key: 3022555 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01858
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE PROXIMAL END OF THE BALLOON WAS BUNCHED-UP. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. AFTER CONFIRMING THE DEVICE MAINTAINED RBP, THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. FUNCTIONAL TESTING REVEALED NO EVIDENCE OF THE ALLEGED BALLOON BURST. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE AND REMOVAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 2.5X20MM NON-BSC BALLOON. DILATION WAS THE PERFORMED WITH THE 1.5X8MM APEX PUSH BALLOON; HOWEVER, THE BALLOON RUPTURED UPON THE THIRD INFLATION TO 20 ATM. THE RUPTURED BALLOON CATHETER WAS DIFFICULT TO REMOVE SO THE PHYSICIAN DECIDED TO REMOVE THE BALLOON AND GUIDE WIRE WAS A UNIT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. 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, A BALLOON RUPTURE AND REMOVAL DIFFICULTIES OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH A 2.5X20MM NON-BSC BALLOON. DILATION WAS THE PERFORMED WITH THE 1.5X8MM APEX PUSH BALLOON; HOWEVER THE BALLOON RUPTURED UPON THE THIRD INFLATION TO 20 ATM. THE RUPTURED BALLOON CATHETER WAS DIFFICULT TO REMOVE SO THE PHYSICIAN DECIDED TO REMOVE THE BALLOON AND GUIDE WIRE WAS A UNIT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125010 APEX? PUSH CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493896008150 15324556

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR GUIDE WIRE: CHOICE PT ES| GUIDE CATHETER: 7F JR 4.0 SH LAUNCHER| BALLOON CATHETER: RYUJIN PLUS 2.50X20MM