BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX PTCA DILATATION CATHETER

    MDR report key: 2170549 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02822
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    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

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN AND CONTRAST ONLY IN THE BALLOON. THE BALLOON WAS IN A DEFLATED STATE. USING AN INFLATION DEVICE (TO 6ATM) A PINHOLE WITH A SCRATCH (2MM) WAS LOCATED IN THE BALLOON MATERIAL ON THE DISTAL END OF THE DISTAL MARKERBAND. THERE WAS A SHAFT KINK 3MM FROM GUIDEWIRE EXIT NOTCH. MICROSCOPIC INSPECTION OF THE BALLOON MATERIAL AND THE REMAINDER OF THE DEVICE REVEALED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGED BALLOON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-02821, 2134265-2011-02823. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER THE UNSPECIFIED GUIDE WIRE CROSSED THE LESION, A 3.25X8MM QUANTUM APEX BALLOON WAS ADVANCED TO PRE-DILATE THE TARGET LESION BUT RUPTURED ON THE FIRST INFLATION AT AROUND 18 ATM'S. THEN A SECOND 3.25X8MM QUANTUM APEX WAS ADVANCED AND ALSO RUPTURED AT AROUND 18 ATM'S. A THIRD 3.25X8MM QUANTUM APEX BALLOON WAS ADVANCED AND AGAIN RUPTURED AT 18 ATM'S. THE PROCEDURE WAS COMPLETED WITH A 3.25X12MM NON BSC BALLOON WITHOUT COMPLICATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-02821, 2134265-2011-02823. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE TARGET LESION LOCATED IN THE SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER THE UNSPECIFIED GUIDE WIRE CROSSED THE LESION, A 3.25X8MM QUANTUM APEX BALLOON WAS ADVANCED TO PRE-DILATE THE TARGET LESION BUT RUPTURED ON THE FIRST INFLATION AT AROUND 18 ATM'S. THEN A SECOND 3.25X8MM QUANTUM APEX WAS ADVANCED AND ALSO RUPTURED AT AROUND 18 ATM'S. A THIRD 3.25X8MM QUANTUM APEX BALLOON WAS ADVANCED AND AGAIN RUPTURED AT 18 ATM'S. THE PROCEDURE WAS COMPLETED WITH A 3.25X12MM NON BSC BALLOON WITHOUT COMPLICATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC QUANTUM APEX PTCA DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408320 14023180

    Patients

    Seq Age Sex Outcome Treatment
    1 3.25X8MM QUANTUM APEX BALLOON| 3.25X8MM QUANTUM APEX BALLOON