BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3030737 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01891
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 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

    DEVICE EVALUATED BY MANUFACTURER: THE MID-SHAFT WAS KINKED 8MM FROM THE GUIDEWIRE EXIT NOTCH. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, WATER EMITTED FROM THE TIP. THERE WAS A HOLE IN THE OUTER SHAFT 10MM FROM THE DISTAL END OF THE GUIDEWIRE EXIT NOTCH. THE HOLE MAY BE CONSISTENT WITH PERFORATION OF THE SHAFT WALL DURING INTERACTION WITH OTHER DEVICES DURING THE PROCEDURE. THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED BALLOON BURST; THOUGH THERE WAS NO DAMAGE TO THE BALLOON; FUNCTIONAL TESTING CONFIRMED A HOLE IN THE OUTER SHAFT PREVENTED BALLOON INFLATION. IN SUMMARY, THE RETURNED DEVICE EXHIBITED DAMAGE CONSISTENT WITH THE REPORTED BALLOON BURST; HOWEVER, THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE REPORTED EVENT OR THE CONFIRMED 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

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-01893. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 75% STENOSED AND UNCALCIFIED TARGET LESION WAS FOUND IN A MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY. A 20X2.25 PROMUS ELEMENT PLUS (PEP) DRUG-ELUTING STENT WAS USED TO TREAT THE TARGET LESION. THE PEP WAS DEPLOYED TO THE TARGET LESION AND POST-DILATION WAS PERFORMED WITH AN 8X2.25MM NON-BSC BALLOON CATHETER. THERE WAS A POSSIBILITY THAT THE PEP STENT WAS NOT WELL APPOSED. IVUS CATHETER WAS THEN ADVANCED BUT WAS UNABLE TO CROSS THE LESION. STENT DEFORMATION OF PEP WAS THEN NOTED, AND THE STENT WAS FOUND TO HAVE SHORTENED IN AN INWARD MANNER. THEY ATTEMPTED TO USE A 15X2.0MM EMERGE BALLOON CATHETER TO INFLATE THE DEFORMED END OF THE PEP BUT IT WAS UNABLE TO CROSS THE STENT. THE EMERGE WAS REPLACED WITH AN 8X1.25MM NON-BSC DEVICE AND DILATATION WAS PERFORMED. ANOTHER DILATATION WAS ATTEMPTED WITH AN 8X2.75MM QUANTUM APEX BALLOON CATHETER BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES AT UNKNOWN NUMBER OF INFLATIONS. THE QUANTUM APEX WAS REPLACED WITH ANOTHER NON-BSC DEVICE AND DILATATION WAS PERFORMED. THEN, A NON-BSC STENT WAS PROXIMALLY DEPLOYED OVERLAPPING THE STENT DEFORMATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-01893. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 75% STENOSED AND UNCALCIFIED TARGET LESION WAS FOUND IN A MODERATELY TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY. A 20X2.25 PROMUS ELEMENT PLUS (PEP) DRUG-ELUTING STENT WAS USED TO TREAT THE TARGET LESION. THE PEP WAS DEPLOYED TO THE TARGET LESION AND POST-DILATION WAS PERFORMED WITH AN 8X2.25MM NON-BSC BALLOON CATHETER. THERE WAS A POSSIBILITY THAT THE PEP STENT WAS NOT WELL APPOSED. IVUS CATHETER WAS THEN ADVANCED BUT WAS UNABLE TO CROSS THE LESION. STENT DEFORMATION OF PEP WAS THEN NOTED, AND THE STENT WAS FOUND TO HAVE SHORTENED IN AN INWARD MANNER. THEY ATTEMPTED TO USE A 15X2.0MM EMERGE BALLOON CATHETER TO INFLATE THE DEFORMED END OF THE PEP BUT IT WAS UNABLE TO CROSS THE STENT. THE EMERGE WAS REPLACED WITH AN 8X1.25MM NON-BSC DEVICE AND DILATATION WAS PERFORMED. ANOTHER DILATATION WAS ATTEMPTED WITH AN 8X2.75MM QUANTUM APEX BALLOON CATHETER BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES AT UNKNOWN NUMBER OF INFLATIONS. THE QUANTUM APEX WAS REPLACED WITH ANOTHER NON-BSC DEVICE AND DILATATION WAS PERFORMED. THEN, A NON-BSC STENT WAS PROXIMALLY DEPLOYED OVERLAPPING THE STENT DEFORMATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134362 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912408270 15294464

    Patients

    Seq Age Sex Outcome Treatment
    1