BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX¿

    MDR report key: 3030795 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01980
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 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

    UPDATED: CONTACT OFFICE NAME, DEVICE EVALUATED BY MFR, EVAL. DEVICE EVALUATION: THE NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE A NC QUANTUM APEX PRODUCT POUCH THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS A COMPLETE CIRCUMFERENTIAL TEAR OF THE BALLOON 12MM FROM THE PROXIMAL BALLOON BOND. THE INNER SHAFT WAS DETACHED ADJACENT TO THE BI-COMPONENT WELD. THE INNER SHAFT FRACTURE FACE WAS JAGGED AND STRETCHED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD. MAGNIFIED INSPECTION OF THE INNER SHAFT FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. THE DISTAL PORTION (INCLUDING INNER SHAFT, BALLOON, MARKERBANDS, TIP) WERE NOT RETURNED FOR ANALYSIS. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-01979. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE AND DISTAL SHAFT BREAK OCCURRED. ACCESS WAS OBTAINED THROUGH THE LEFT FEMORAL ARTERY. THE 90% STENOTIC, DE NOVO, 3.5MM IN DIAMETER - SHORT LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). AFTER ROTABLATION INTERVENTION THE PHYSICIAN USED SEVERAL BALLOONS TO PREDILATE THE LESION PRIOR TO ADVANCING A 3.5X15MM NC QUANTUM APEX BALLOON TO THE LESION. THE BALLOON WAS INFLATED TO 30ATMS SEVERAL TIMES AND THEN THE BALLOON RUPTURED. WHEN THE BALLOON WAS PULLED BACK INTO THE GUIDE CATHETER, THE DISTAL SHAFT SEPARATED. THE DETACHED DISTAL SHAFT WAS REMOVED WITH THE GUIDE CATHETER. ANOTHER 3.5X15MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LESION AND INFLATED SEVERAL TIMES AND THEN RUPTURED. WHEN THE BALLOON WAS PULLED BACK INTO THE GUIDE CATHETER, THE DISTAL SHAFT SEPARATED. THE DETACHED DISTAL SHAFT WAS REMOVED WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND STENTING OF THE RCA WITH GOOD ANGIOGRAPHIC RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2013-01979. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE AND DISTAL SHAFT BREAK OCCURRED. ACCESS WAS OBTAINED THROUGH THE LEFT FEMORAL ARTERY. THE 90% STENOTIC, DE NOVO, 3.5MM IN DIAMETER - SHORT LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). AFTER ROTABLATION INTERVENTION THE PHYSICIAN USED SEVERAL BALLOONS TO PREDILATE THE LESION PRIOR TO ADVANCING A 3.5X15MM NC QUANTUM APEX BALLOON TO THE LESION. THE BALLOON WAS INFLATED TO 30ATMS SEVERAL TIMES AND THEN THE BALLOON RUPTURED. WHEN THE BALLOON WAS PULLED BACK INTO THE GUIDE CATHETER, THE DISTAL SHAFT SEPARATED. THE DETACHED DISTAL SHAFT WAS REMOVED WITH THE GUIDE CATHETER. ANOTHER 3.5X15MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LESION AND INFLATED SEVERAL TIMES AND THEN RUPTURED. WHEN THE BALLOON WAS PULLED BACK INTO THE GUIDE CATHETER, THE DISTAL SHAFT SEPARATED. THE DETACHED DISTAL SHAFT WAS REMOVED WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND STENTING OF THE RCA WITH GOOD ANGIOGRAPHIC RESULT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134320 NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415350 15662373

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 3.5 X 20MM EMERGE BALLOON CATHETER| ROTAWIRE GUIDE WIRE| JR-5 8F LAUNCHER GUIDE CATHETER| 1.25MM ROTALINK BURR