BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETIX?

    MDR report key: 3221215 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04710
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K081021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. THE DISTAL TIP WAS DETACHED. THE CORE WIRE AND HIGH TORQUE SLEEVE (HTS) WERE FRACTURED. THE REMAINING HTS MEASURED 6" LONG FROM THE FRACTURE TO THE ADHESIVE RAMP. MAGNIFIED INSPECTION OF THE FRACTURE SURFACES APPEAR TO BE CONSISTENT WITH SEPARATION DUE TO DUCTILE BENDING OVERLOAD. MAGNIFIED INSPECTION OF THE FRACTURED ENDS OF THE CORE WIRE REVEALED THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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 CORONARY STENTING TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS PROXIMAL END TO MID, 3.7MM IN DIAMETER, LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED A 185CM KINETIX GUIDE WIRE TO CROSS THE LESION. IT WAS PREDILATED WITH AN UNKNOWN BALLOON CATHETER AND PRE-IVUS WAS PERFORMED. AFTER A 3.5MM NON-BSC STENT WAS DEPLOYED AND THE LESION WAS POSTDILATED WITH A 3.75MM UNKNOWN BALLOON CATHETER, THE PHYSICIAN TRIED TO REMOVE THE GUIDE WIRE FROM THE PATIENT, HOWEVER, ANGIOGRAPHY SHOWED IT WAS SEPARATED AT PROXIMAL END OF LAD AND A PORTION REMAINED IN THE CORONARY. IN ORDER TO REMOVE THE REMAINED PORTION OF THE GUIDE WIRE, A NON-BSC CATHETER AND 2 GUIDE WIRES WERE INSERTED BUT FAILED. A 4MM NON-BSC SNARE WAS THEN USED TO RETRIEVE THE REMAINED PORTION OF THE GUIDE WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CORONARY STENTING TREATMENT PROCEDURE, A GUIDE WIRE DETACHMENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS PROXIMAL END TO MID, 3.7MM IN DIAMETER, LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED A 185CM KINETIX GUIDE WIRE TO CROSS THE LESION. IT WAS PREDILATED WITH AN UNKNOWN BALLOON CATHETER AND PRE-IVUS WAS PERFORMED. AFTER A 3.5MM NON-BSC STENT WAS DEPLOYED AND THE LESION WAS POSTDILATED WITH A 3.75MM UNKNOWN BALLOON CATHETER, THE PHYSICIAN TRIED TO REMOVE THE GUIDE WIRE FROM THE PATIENT, HOWEVER, ANGIOGRAPHY SHOWED IT WAS SEPARATED AT PROXIMAL END OF LAD AND A PORTION REMAINED IN THE CORONARY. IN ORDER TO REMOVE THE REMAINED PORTION OF THE GUIDE WIRE, A NON-BSC CATHETER AND 2 GUIDE WIRES WERE INSERTED BUT FAILED. A 4MM NON-BSC SNARE WAS THEN USED TO RETRIEVE THE REMAINED PORTION OF THE GUIDE WIRE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320406 KINETIX? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74939122010 15101693

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: MACH 1 6F JL4.0| STENT: 3.5MM ENDEAVOR MEDTRONIC