BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 8870767 · Received August 7, 2019

    Report

    Report Number
    3005099803-2019-03981
    Event Type
    Injury
    Date Received
    August 7, 2019
    Date of Event
    July 1, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    UDI-DI
    08714729376361
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 (DATE OF EVENT): THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2019 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. BLOCK H6 (DEVICE CODES): PROBLEM CODE 2907 CAPTURES THE REPORTABLE EVENT OF DETACHMENT OF DEVICE COMPONENT THAT HAD TO BE RETRIEVED. BLOCK H10: A VISUAL EXAMINATION WAS PERFORMED AND IT WAS NOTED THAT ONLY THE SHRINK SLEEVE WAS RETURNED FOR ANALYSIS. THE SHRINK SLEEVE WAS FOUND DETACHED AND STRETCHED. THE COMPLAINT WAS CONSISTENT WITH THE REPORTED EVENT OF PROXIMAL PART OF THE SENSOR GUIDEWIRE WAS DETACHED. THERE WAS EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. THEREFORE, THE CONCLUSION CODE OF FAILURE TO FOLLOW INSTRUCTIONS WAS SELECTED SINCE THE USER DID NOT FOLLOW THE INSTRUCTION STATED ON THE DFU.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED DURING A STENT PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, IN (B)(6) 2018, PERCUTANEOUS NEPHROLITHOTOMY (PNL) WAS PERFORMED FOR KIDNEY STONE. IN (B)(6) 2018, A DOUBLE J (DJ) STENT WAS PLACED DUE TO STENOTIC PYELONEPHRITIS. IN 2019, THE DJ STENT WAS REPLACED TWICE AS PERIODIC EXCHANGE (EXACT DATES UNKNOWN). REPORTEDLY, THERE WAS NO COMPLAINT AGAINST THE DJ STENT. IN (B)(6) 2019, WHEN THE DJ STENT WAS REPLACED, THE PHYSICIAN NOTICED A FOREIGN OBJECT ON AN X-RAY IMAGE, IT WAS REMOVED USING URETEROSCOPE. ACCORDING TO THE NURSE, THERE IS A HIGH POSSIBILITY THAT THE DETACHMENT OF THE FOREIGN OBJECT HAPPENED EITHER DURING THE PNL IN (B)(6) 2018 OR THE POLARIS ULTRA STENT PLACEMENT IN (B)(6) 2018. IN THE PHYSICIAN'S ASSESSMENT, THE FOREIGN OBJECT RETRIEVED COULD BE THE PROXIMAL PART OF THE SENSOR GUIDEWIRE AS THE GUIDEWIRE WAS INSERTED TO WIDEN AN OCCLUSION INSIDE THE DJ STENT AND ANOTHER GUIDEWIRE IS USED IF THERE IS AN OCCLUSION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE (B)(6) 2019 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME. (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSOR GUIDEWIRE WAS USED DURING A STENT PLACEMENT PROCEDURE. THE EXACT PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, IN (B)(6) 2018, PERCUTANEOUS NEPHROLITHOTOMY (PNL) WAS PERFORMED FOR KIDNEY STONE. IN (B)(6) 2018, A DOUBLE J (DJ) STENT WAS PLACED DUE TO STENOTIC PYELONEPHRITIS. IN 2019, THE DJ STENT WAS REPLACED TWICE AS PERIODIC EXCHANGE (EXACT DATES UNKNOWN). REPORTEDLY, THERE WAS NO COMPLAINT AGAINST THE DJ STENT. IN (B)(6) 2019, WHEN THE DJ STENT WAS REPLACED, THE PHYSICIAN NOTICED A FOREIGN OBJECT ON AN X-RAY IMAGE, IT WAS REMOVED USING URETEROSCOPE. ACCORDING TO THE NURSE, THERE IS A HIGH POSSIBILITY THAT THE DETACHMENT OF THE FOREIGN OBJECT HAPPENED EITHER DURING THE PNL IN (B)(6) 2018 OR THE POLARIS ULTRA STENT PLACEMENT IN (B)(6) 2018. IN THE PHYSICIAN'S ASSESSMENT, THE FOREIGN OBJECT RETRIEVED COULD BE THE PROXIMAL PART OF THE SENSOR GUIDEWIRE AS THE GUIDEWIRE WAS INSERTED TO WIDEN AN OCCLUSION INSIDE THE DJ STENT AND ANOTHER GUIDEWIRE IS USED IF THERE IS AN OCCLUSION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663227 SENSOR STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION M0066703080 08714729376361

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention