BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEZILLA¿

    MDR report key: 6838206 · Received September 1, 2017

    Report

    Report Number
    2134265-2017-08687
    Event Type
    Malfunction
    Date Received
    September 1, 2017
    Date of Event
    August 13, 2017
    Report Date
    August 14, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K123765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE HUB, HYPOTUBE, COLLAR, DISTAL SHAFT AND TIP OF THE DEVICE WAS MICROSCOPICALLY, TACTILE AND VISUALLY INSPECTED. INSPECTION REVEALED A KINK IN THE DISTAL SHAFT LOCATED 1 CM FROM THE TIP OF THE DEVICE, TIP DAMAGE (ABRASION) AND A COMPLETE SEPARATION OF THE SHAFT AT THE COLLAR WITH THE PTFE FULLY PULLED OUT FROM COLLAR. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USE/USER ERROR AS THE DFU STATES: ¿THE GUIDEZILLA GUIDE EXTENSION CATHETER IS INTENDED TO BE USED IN CONJUNCTION WITH GUIDE CATHETERS TO ACCESS DISCRETE REGIONS OF THE CORONARY AND/OR PERIPHERAL VASCULATURE, AND TO FACILITATE PLACEMENT OF INTERVENTIONAL DEVICES¿. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER SHAFT DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. A GUIDEZILLA¿ GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, A NON BSC STENT WAS DELIVERED TO THE LESION; HOWEVER IT WAS NOTICED THAT THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). CONSEQUENTLY, THE GUIDEZILLA¿ WAS DELIVERED TO REMOVE THE STENT; HOWEVER, THE COLLAR OF THE DEVICE BECAME SEPARATED. FURTHERMORE, THE SEPARATED COLLAR REMAINED INSIDE A NON BSC GUIDING CATHETER AND WAS REMOVED FROM THE PATIENT AS A SINGLE UNIT WITH THE GUIDING CATHETER. THE DISLODGED NON BSC STENT COULD NOT BE REMOVED FROM THE PATIENT AND WAS PUSHED AGAINST THE VESSEL WALL. THE PROCEDURE WAS NOT COMPLETED AS THE SAME DEVICE WAS UNAVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CATHETER SHAFT DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT CIRCUMFLEX (LCX) ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, A NON BSC STENT WAS DELIVERED TO THE LESION; HOWEVER IT WAS NOTICED THAT THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). CONSEQUENTLY, THE GUIDEZILLA WAS DELIVERED TO REMOVE THE STENT; HOWEVER, THE COLLAR OF THE DEVICE BECAME SEPARATED. FURTHERMORE, THE SEPARATED COLLAR REMAINED INSIDE A NON BSC GUIDING CATHETER AND WAS REMOVED FROM THE PATIENT AS A SINGLE UNIT WITH THE GUIDING CATHETER. THE DISLODGED NON BSC STENT COULD NOT BE REMOVED FROM THE PATIENT AND WAS PUSHED AGAINST THE VESSEL WALL. THE PROCEDURE WAS NOT COMPLETED AS THE SAME DEVICE WAS UNAVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619244 GUIDEZILLA¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H7493924215050 20858146

    Patients

    Seq Age Sex Outcome Treatment
    1