BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTALINK CATHETER

    MDR report key: 1251996 · Received December 4, 2008

    Report

    Report Number
    2134265-2008-04591
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS DID NOT CONFIRM THE COMPLAINT. THE CATHETER WAS EXAMINED FOR KINKS AND NONE WERE FOUND. THE CATHETER WAS CONNECTED TO A TEST ADVANCER. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION AND NO DAMAGE WAS NOTED WITH THE UNIT'S HANDSHAKE CONNECTIONS. THE CATHETER WAS WIRE GUIDED USING A TEST WIRE GUIDE AND NO ISSUES WERE NOTED. THE CATHETER WAS WET TESTED USING THE TEST ADVANCER AND NO ISSUES WERE NOTED. A SCRATCH TEST WAS PERFORMED AND THIS CONFIRMED THAT THE BURR'S CUTTING ACTION WAS ACCEPTABLE. THE BURR WAS MICROSCOPICALLY EXAMINED AND THE BURR WAS WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD FOR THIS DEVICE HAS BEEN REVIEWED FOR MANUFACTURING ISSUES AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD RELATE TO THIS COMPLAINT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. THE COMPLAINT DEVICE MET BOSTON SCIENTIFIC DESIGN AND MANUFACTURING SPECIFICATION, BUT DUE TO AN ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, THE BURR BECAME STUCK IN THE LESION. THE HEAVILY CALCIFIED LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE ROTABLATOR SYSTEM WAS SET AT 140K RPMS DURING PLATFORMING. FOLLOWING ABLATION WITH A 1.25MM BURR, THIS 1.5MM BURR WAS ADVANCED TO THE LESION. NO ABLATION RUNS WERE REPORTED TO BE COMPLETED; HOWEVER, THE BURR BECAME STUCK IN THE LESION. A SMALL 1.25MM BALLOON WAS USED TO DILATE BETWEEN THE BURR AND THE ARTERY, AND THE ROTALINK BURR WAS ABLE TO BE REMOVED. THE DELAY WAS APPROXIMATELY 30-60 MINUTES, HOWEVER, NO ADVERSE PATIENT SYMPTOMS WERE REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. PATIENT STATUS WAS REPORTED AS 'STABLE'. IN THE OPINION OF THE PHYSICIAN, THE BURR BECAME STUCK DUE TO THE HEAVY CALCIFICATION. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK CATHETER MCX CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CVA21 11141927

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention