BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFLEX¿

    MDR report key: 2945719 · Received February 6, 2013

    Report

    Report Number
    2134265-2013-00365
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE MID-SHAFT WAS STRETCHED. THERE WAS A COMPLETE MID-SHAFT SEPARATION 15.5CM FROM THE MID-SHAFT/HYPOTUBE BOND. THE FRACTURE FACES WERE JAGGED AND STRETCHED. A MAGNIFIED INSPECTION OF THE FRACTURE SURFACE PRESENTED NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SEPARATION. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE PROCEDURE TREATED THE DE NOVO, 90% STENOSED 5.5X22MM TARGET LESION LOCATED IN THE PROXIMAL PORTION OF A SAPHENOUS VEIN GRAFT TO THE LEFT POSTERIOR DESCENDING ARTERY. THERE WAS NO VESSEL CALCIFICATION OR TORTUOUSITY. USING A DIRECT STENTING TECHNIQUE, A 5.0X24MM VERIFLEX STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. HOWEVER UPON WITHDRAWAL, THE STENT DELIVERY SYSTEM HIT THE TIP OF THE NON-BSC GUIDE CATHETER SHEARING OFF THE MID AND DISTAL PORTIONS OF THE VERIFLEX CATHETER. THE NON-BSC GUIDE CATHETER WAS THEN REMOVED AND IT WAS NOTED THAT THE TIP OF THE VERIFLEX CATHETER AND BALLOON REMAINED INSIDE OF THE GUIDE CATHETER AND WERE REMOVED WITH THE GUIDE CATHETER. IT WAS NOTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY IN THE VEIN GRAFT PRIOR TO THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE PROCEDURE TREATED THE DE NOVO, 90% STENOSED 5.5X22MM TARGET LESION LOCATED IN THE PROXIMAL PORTION OF A SAPHENOUS VEIN GRAFT TO THE LEFT POSTERIOR DESCENDING ARTERY. THERE WAS NO VESSEL CALCIFICATION OR TORTUOUSITY. USING A DIRECT STENTING TECHNIQUE, A 5.0X24MM VERIFLEX STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. HOWEVER UPON WITHDRAWAL, THE STENT DELIVERY SYSTEM HIT THE TIP OF THE NON-BSC GUIDE CATHETER SHEARING OFF THE MID AND DISTAL PORTIONS OF THE VERIFLEX CATHETER. THE NON-BSC GUIDE CATHETER WAS THEN REMOVED AND IT WAS NOTED THAT THE TIP OF THE VERIFLEX CATHETER AND BALLOON REMAINED INSIDE OF THE GUIDE CATHETER AND WERE REMOVED WITH THE GUIDE CATHETER. IT WAS NOTED THAT THE PATIENT UNDERWENT OPEN HEART SURGERY IN THE VEIN GRAFT PRIOR TO THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50244 VERIFLEX¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893424500 15688686

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CHOICE PT FLOPPY GUIDE WIRE