BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX¿

    MDR report key: 16536613 · Received March 14, 2023

    Report

    Report Number
    16536613
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729031857
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE INTERVENTIONAL RADIOLOGIST SCHEDULED THE PATIENT FOR A PROCEDURE DURING WHICH HE INTENDED TO REMOVE THE PATIENT'S LEFT NEPHROURETERAL CATHETER AND REPLACE IT WITH A DOUBLE-J STENT. THE PHYSICIAN HAD SUCCESSFULLY REMOVED THE NEPHROURETERAL CATHETER OVER A GUIDEWIRE AND THEN PLACED AN 11 FRENCH PEEL-AWAY SHEATH. A 10 FRENCH BY 26-CM DOUBLE-J STENT WAS THEN ADVANCED OVER THE GUIDEWIRE. AFTER DEPLOYMENT OF THE STENT, IT PROMPTLY MIGRATED DISTALLY WITH THE DEFORMED PROXIMAL RETENTION LOOP "KINKING" IN THE URETER APPROXIMATELY 5-7 CM FROM THE RENAL PELVIS. THE EXTERNAL RETENTION "SUTURE" WAS FOUND TO BE UNASSOCIATED/DETACHED FROM THE PROXIMAL ASPECT OF THE DOUBLE J STENT UPON APPLYING TENSION TO IT. EXTENSIVE ATTEMPTS TO REPOSITION THE STENT USING VASCULAR SNARES AND MULTIPLE CATHETER AND GUIDEWIRE COMBINATIONS WERE ATTEMPTED BUT WERE UNSUCCESSFUL. THE STENT COULD NOT BE APPROPRIATELY ENGAGED AT ITS PROXIMAL ASPECT. MULTIPLE ATTEMPTS WERE MADE AT PASSAGE OF A GUIDEWIRE INTO THE STENT, WITHOUT SUCCESS. THEREFORE, A GUIDEWIRE WAS ADVANCED INTO THE URINARY BLADDER AND A VASCULAR SNARE WAS USED TO ENGAGE THE DISTAL ASPECT OF THE DOUBLE-J STENT WITHIN THE URINARY BLADDER. A SECOND 5 FRENCH CATHETER WAS ADVANCED INTO THE URINARY BLADDER IN AN ATTEMPT TO MAINTAIN ACCESS. THE DISTAL ASPECT OF THE STENT WAS THEN WITHDRAWN THROUGH THE URETER INTO THE RENAL PELVIS. DURING ATTEMPTS AT REMOVING THE DOUBLE-J STENT COMPLETELY, THE SNARE SEVERED THE DOUBLE-J STENT APPROXIMATELY MIDWAY FROM THE SKIN ENTRY SITE AND THE ENTRY SITE TO THE RENAL CAPSULE. LIMITED ATTEMPTS WERE MADE THROUGH THE EXISTING MINIMAL INCISION TO DISSECT DOWN ONTO THE STENT REMNANT FOR REMOVAL. THE COULD NOT BE SUCCESSFULLY ACHIEVED, SO THE PROCEDURE WAS MODIFIED AND COMPLETED WITH THE STENT REMNANT REMAINING INSIDE THE PATIENT.

    Description of Event or Problem · 0

    THE INTERVENTIONAL RADIOLOGIST SCHEDULED THE PATIENT FOR A PROCEDURE DURING WHICH HE INTENDED TO REMOVE THE PATIENT'S LEFT NEPHROURETERAL CATHETER AND REPLACE IT WITH A DOUBLE-J STENT. THE PHYSICIAN HAD SUCCESSFULLY REMOVED THE NEPHROURETERAL CATHETER OVER A GUIDEWIRE AND THEN PLACED AN 11 FRENCH PEEL-AWAY SHEATH. A 10 FRENCH BY 26-CM DOUBLE-J STENT WAS THEN ADVANCED OVER THE GUIDEWIRE. AFTER DEPLOYMENT OF THE STENT, IT PROMPTLY MIGRATED DISTALLY WITH THE DEFORMED PROXIMAL RETENTION LOOP "KINKING" IN THE URETER APPROXIMATELY 5-7 CM FROM THE RENAL PELVIS. THE EXTERNAL RETENTION "SUTURE" WAS FOUND TO BE UNASSOCIATED/DETACHED FROM THE PROXIMAL ASPECT OF THE DOUBLE J STENT UPON APPLYING TENSION TO IT. EXTENSIVE ATTEMPTS TO REPOSITION THE STENT USING VASCULAR SNARES AND MULTIPLE CATHETER AND GUIDEWIRE COMBINATIONS WERE ATTEMPTED BUT WERE UNSUCCESSFUL. THE STENT COULD NOT BE APPROPRIATELY ENGAGED AT ITS PROXIMAL ASPECT. MULTIPLE ATTEMPTS WERE MADE AT PASSAGE OF A GUIDEWIRE INTO THE STENT, WITHOUT SUCCESS. THEREFORE, A GUIDEWIRE WAS ADVANCED INTO THE URINARY BLADDER AND A VASCULAR SNARE WAS USED TO ENGAGE THE DISTAL ASPECT OF THE DOUBLE-J STENT WITHIN THE URINARY BLADDER. A SECOND 5 FRENCH CATHETER WAS ADVANCED INTO THE URINARY BLADDER IN AN ATTEMPT TO MAINTAIN ACCESS. THE DISTAL ASPECT OF THE STENT WAS THEN WITHDRAWN THROUGH THE URETER INTO THE RENAL PELVIS. DURING ATTEMPTS AT REMOVING THE DOUBLE-J STENT COMPLETELY, THE SNARE SEVERED THE DOUBLE-J STENT APPROXIMATELY MIDWAY FROM THE SKIN ENTRY SITE AND THE ENTRY SITE TO THE RENAL CAPSULE. LIMITED ATTEMPTS WERE MADE THROUGH THE EXISTING MINIMAL INCISION TO DISSECT DOWN ONTO THE STENT REMNANT FOR REMOVAL. THE COULD NOT BE SUCCESSFULLY ACHIEVED, SO THE PROCEDURE WAS MODIFIED AND COMPLETED WITH THE STENT REMNANT REMAINING INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767537 PERCUFLEX¿ STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M001235600 25746917 08714729031857

    Patients

    Seq Age Sex Outcome Treatment
    1 26645 DA Male