BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEZILLA II PV LONG GUIDE EXTENSION CATHETER

    MDR report key: 7916032 · Received September 27, 2018

    Report

    Report Number
    2134265-2018-61374
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 30, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED. A 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEZILLA WAS CAUGHT ON THE PROTRUSION OF A NON BSC DEVICE AND STOPPED MOVING EVEN THOUGH IT WAS PUSHED AND PULLED. FURTHERMORE, AFTER THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE GUIDEZILLA SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF A 6F LONG GUIDEZILLA 2 GUIDE EXTENSION CATHETER AND A NON-BSC 6.0MM X 40 MM PERIPHERAL BALLOON CATHETER. THE BALLOON CATHETER WAS RECEIVED INSIDE THE GUIDEZILLA DISTAL SHAFT, WITH THE BALLOON FOLDED AND OUTSIDE OF THE TIP (DISTAL TO) OF THE GUIDEZILLA. THE OUTER DIAMETER (OD) OF THE BALLOON WAS MEASURED (WITH A CALIBRATED MICROMETER) TO BE .071. THE BALLOON CATHETER WAS REMOVED FROM THE GUIDEZILLA SHAFT DURING THE LAB ANALYSIS, AND IT TOOK SOME EFFORT AS THE BALLOON WAS A VERY TIGHT FIT. THE DEVICES WERE BLOODY. THE HYPOTUBE, COLLAR, DISTAL SHAFT AND TIP WERE MICROSCOPICALLY AND VISUALLY INSPECTED. INSPECTION REVEALED A KINK IN THE HYPOTUBE LOCATED 25 CM FROM THE STRAIN RELIEF, A COMPLETE SEPARATION AT THE DISTAL END OF THE COLLAR/SHAFT AREA, AND COLLAR DAMAGE (COLLAR BENT/SHAFT AND METAL PARTIALLY SEPARATING/STRETCHING). THE TIP OF THE GUIDEZILLA WAS MEASURED WITH A CALIBRATED PIN GAGE AND WAS FOUND TO MEET THE GUIDEZILLA SPECIFICATION. THE DAMAGE TO THE DEVICE IS CONSISTENT WITH THE REPORTED INFORMATION. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED. A 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEZILLA WAS CAUGHT ON THE PROTRUSION OF A NON BSC DEVICE AND STOPPED MOVING EVEN THOUGH IT WAS PUSHED AND PULLED. FURTHERMORE, AFTER THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE GUIDEZILLA SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754491 GUIDEZILLA II PV LONG GUIDE EXTENSION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORPORATION 24982 0022092469

    Patients

    Seq Age Sex Outcome Treatment
    1 BALLOON CATHETER: MASTULY| BALLOON CATHETER: MASTULY 6.0MM X 40 MM| GUIDEWIRE: HALBERD| GUIDEWIRE: HALBERD| INTRODUCER SHEATH: PARENT 4.5| INTRODUCER SHEATH: PARENT 4.5