BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 8455300 · Received March 27, 2019

    Report

    Report Number
    2134265-2019-02953
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    February 6, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXO
    UDI-DI
    08714729904397
    PMA / PMN Number
    K151610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO (EVALUATION CONCLUSION CODE): CHANGED FROM DESIGN INADEQUATE FOR PURPOSE TO UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. CORRECTION TO (DEVICE EVALUATION): CHANGED FROM: DEVICE EVALUATED BY MFR: THE SHAFT SHOWED 1 KINK LOCATED AT THE OCB HANDLE. THE TIP SHOWED STRETCHED COILS. THERE WAS SOME COATING PEELED FROM THE WIRE AT THE 93CM KINKED AREA. THERE WAS INDICATION OF BODY FLUIDS IN THE SENSOR HOUSING. THE COMET WIRE WAS NOT CONNECTED TO THE OCB WHEN RETURNED. THE WIRE WAS CONNECTED TO THE HANDLE TO CHECK SIGNAL STRENGTH. THE SIGNAL WAS NOT PRESENT AS DESIGNED. THE WIRE WAS REMOVED FROM THE OCB HANDLE WITH A RESTRICTION. IT DID TAKE A FAIR AMOUNT OF TENSILE PULL TO REMOVE IT. THE INSIDE OF THE CAP WAS INSPECTED AND FOUND THAT THERE WAS DAMAGE. THE COLLET WAS JAMMED IN AND STUCK IN THE CAP WHICH CAUSED THE COLLET NOT TO LET GO OF THE WIRE. IT IS POSSIBLE DURING THE ASSEMBLY PROCESS OF THE OCB HANDLE THE WIRE WAS INSERTED INTO THE COLLET AND AS THE CAP WAS TIGHTENED THE COLLET BECAME SKEWED AND JAMMED IN THE CAP. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE COMPLAINT WAS CONFIRMED FOR UNLOCKING ISSUES. CHANGED TO: DEVICE EVALUATED BY MFR: THE SHAFT SHOWED 4 KINKS. THE KINKS WERE LOCATED AT THE OCB HANDLE, 93CM FROM THE TIP. THE DEVICE SHOWED 2 KINKS INSIDE OF THE OCB HANDLE AT THE COLLET AREA. THE TIP SHOWED A KINK/BENDS AND STRETCHED COILS. THERE WAS SOME COATING PEELED FROM THE WIRE AT THE 93CM KINKED AREA. NO BODY FLUIDS IN THE SENSOR HOUSING. THE COMET WIRE WAS CONNECTED TO THE FFR LINK FOR SIGNAL VERIFICATION. THE SIGNAL WAS NOT PRESENT AS DESIGNED. THE WIRE WAS BEING REMOVED FROM THE OCB HANDLE. THE OCB CONNECTOR CABLE WAS LOOSENED 1 TURN TO REMOVE THE WIRE FROM THE HANDLE. THE WIRE WOULD NOT EXIT THE COLLET OR HANDLE. THE TURN KNOB WAS LOOSENED AND TAKEN OFF THE OCB HANDLE. THE COLLET WAS GENTLY MOVED BACK AND FORTH UNTIL THE COLLECT CAME LOOSE FROM THE CAP. THE INSIDE OF THE CAP WAS INSPECTED AND FOUND THAT THERE WAS DAMAGE. THE COLLET WAS JAMMED IN AND STUCK IN THE CAP WHICH CAUSED THE COLLET NOT TO LET GO OF THE WIRE. IT IS POSSIBLE DURING THE ASSEMBLY PROCESS OF THE OCB HANDLE THE WIRE WAS INSERTED INTO THE COLLET AND AS THE CAP WAS TIGHTENED THE COLLET BECAME SKEWED AND JAMMED IN THE CAP. IF THE WIRE ENTERED THE SLOTS OF THE COLLET AND THE CAP WAS TIGHTENED THE INTERNAL KINKS ON THE WIRE INSIDE OF THE OCB HANDLE MAY HAVE OCCURRED. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIFFICULTY DISCONNECTING A PRESSURE GUIDEWIRE OCCURRED. DURING THE DISCONNECTION OF A COMET FROM THE WIRE CONNECTOR, THE WIRE COULDN'T BE PULLED OUT. AFTER THE PROCEDURE, THE WIRE WAS COMPLETELY DISCONNECTED FROM THE CONNECTOR AND IT WAS NOTICED THAT TWO V SHAPED BENDS WERE PRESENT ON THE HIDDEN PROXIMAL PART OF THE WIRE. FFR WAS NOT PERFORMED WITH THIS WIRE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED/SHEARED COATING.

    Additional Manufacturer Narrative · 1

    THE SHAFT SHOWED 1 KINK LOCATED AT THE OCB HANDLE. THE TIP SHOWED STRETCHED COILS. THERE WAS SOME COATING PEELED FROM THE WIRE AT THE 93CM KINKED AREA. THERE WAS INDICATION OF BODY FLUIDS IN THE SENSOR HOUSING. THE COMET WIRE WAS NOT CONNECTED TO THE OCB WHEN RETURNED. THE WIRE WAS CONNECTED TO THE HANDLE TO CHECK SIGNAL STRENGTH. THE SIGNAL WAS NOT PRESENT AS DESIGNED. THE WIRE WAS REMOVED FROM THE OCB HANDLE WITH A RESTRICTION. IT DID TAKE A FAIR AMOUNT OF TENSILE PULL TO REMOVE IT. THE INSIDE OF THE CAP WAS INSPECTED AND FOUND THAT THERE WAS DAMAGE. THE COLLET WAS JAMMED IN AND STUCK IN THE CAP WHICH CAUSED THE COLLET NOT TO LET GO OF THE WIRE. IT IS POSSIBLE DURING THE ASSEMBLY PROCESS OF THE OCB HANDLE THE WIRE WAS INSERTED INTO THE COLLET AND AS THE CAP WAS TIGHTENED THE COLLET BECAME SKEWED AND JAMMED IN THE CAP. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE COMPLAINT WAS CONFIRMED FOR UNLOCKING ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTY DISCONNECTING A PRESSURE GUIDEWIRE OCCURRED. DURING THE DISCONNECTION OF A COMET FROM THE WIRE CONNECTOR, THE WIRE COULDN'T BE PULLED OUT. AFTER THE PROCEDURE, THE WIRE WAS COMPLETELY DISCONNECTED FROM THE CONNECTOR AND IT WAS NOTICED THAT TWO V SHAPED BENDS WERE PRESENT ON THE HIDDEN PROXIMAL PART OF THE WIRE. FFR WAS NOT PERFORMED WITH THIS WIRE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED/SHEARED COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248896 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0022738882 08714729904397

    Patients

    Seq Age Sex Outcome Treatment
    1