BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18 T3 7/200/135

    MDR report key: 18737812 · Received February 20, 2024

    Report

    Report Number
    1028232-2024-00949
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    February 7, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BIOTRONIK AG, BUELACH, SWITZERLAND
    Product Code
    NIP
    UDI-DI
    07640130447141
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, THE PHYSICIAN DESCRIBED THAT HE FELT THAT THE WHEEL HAD ROTATED AND STOPPED NORMALLY. HE BEGAN RETRACTING THE CATHETER BACK TOWARDS THE SHEATH AND NOTICED RESISTANCE. UNDER FLUOROSCOPY HE DETERMINED THAT THE STENT HAD NOT BEEN RELEASED. THE PHYSICIAN THEN RESUMED RETRACTING THE DEPLOYMENT CATHETER AT WHICH TIME THE STENT RELEASED. AFTER POST-MILITATING, THE STENT WAS DETERMINED TO BE IN AN ACCEPTABLE POSITION. THE PATIENT WAS DISCHARGED WITHOUT INCIDENT. THE PHYSICIAN COULD NOT CONFIRM IF THE RESTRAINING CATHETER WAS FULLY RETRACTED WITH THE STENT STILL ATTACHED BUT HE BELIEVES IT WAS. INVESTIGATION RESULTS: THE RETURNED PRODUCT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. IN THE AS-RETURNED STATE, THE DISTAL END OF THE RETRACTABLE SHAFT WAS LOCATED ABOUT 21 MM PROXIMAL TO THE DISTAL END OF THE STOPPER SHAFT. THE STENT HAS BEEN RELEASED IN THE PATIENTS BODY AND WAS THUS NOT RETURNED. THE RETRACTABLE SHAFT WAS FOUND MILDLY DEFORMED (I.E. FLARED) AT ITS DISTAL END. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITY. OUTSIDE OF THE DEFORMED ZONE, THE DIMENSIONS OF THE DEVICE COMPONENTS COMPLY WITH THE SPECIFICATION. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTED THE INITIAL REPORTER INFORMATION. REFERENCE CAPA# NC-24-004. ADDITIONAL EVENT DESCRIPTION: AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, THE PHYSICIAN DESCRIBED THAT HE FELT THAT THE WHEEL HAD ROTATED AND STOPPED NORMALLY. HE BEGAN RETRACTING THE CATHETER BACK TOWARDS THE SHEATH AND NOTICED RESISTANCE. UNDER FLUOROSCOPY HE DETERMINED THAT THE STENT HAD NOT BEEN RELEASED. THE PHYSICIAN THEN RESUMED RETRACTING THE DEPLOYMENT CATHETER AT WHICH TIME THE STENT RELEASED. AFTER POST-MILITATING, THE STENT WAS DETERMINED TO BE IN AN ACCEPTABLE POSITION. THE PATIENT WAS DISCHARGED WITHOUT INCIDENT. THE PHYSICIAN COULD NOT CONFIRM IF THE RESTRAINING CATHETER WAS FULLY RETRACTED WITH THE STENT STILL ATTACHED BUT HE BELIEVES IT WAS. INVESTIGATION RESULTS: THE RETURNED PRODUCT WAS SUBJECTED TO A DETAILED TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. IN THE AS-RETURNED STATE, THE DISTAL END OF THE RETRACTABLE SHAFT WAS LOCATED ABOUT 21 MM PROXIMAL TO THE DISTAL END OF THE STOPPER SHAFT. THE STENT HAS BEEN RELEASED IN THE PATIENTS BODY AND WAS THUS NOT RETURNED. THE RETRACTABLE SHAFT WAS FOUND MILDLY DEFORMED (I.E. FLARED) AT ITS DISTAL END. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO OTHER DAMAGE OR IRREGULARITY. OUTSIDE OF THE DEFORMED ZONE, THE DIMENSIONS OF THE DEVICE COMPONENTS COMPLY WITH THE SPECIFICATION. REVIEW OF THE PRODUCTION DOCUMENTATION CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. BASED ON THE CONDUCTED INVESTIGATIONS OF THE DEVICE BEING SUBJECT TO THIS COMPLAINT, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 0

    A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT. THE RATCHET RELEASE WHEEL STOPPED PRIOR TO RELEASING THE ENTIRE 200MM STENT. THE OPERATOR WAS ABLE TO GET THE STENT OFF THE DELIVERY SYSTEM AND USED A PTA BALLOON AND STENT TO COMPLETE THE CASE. THE STENT REMAINED IN THE VESSEL AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087018 PULSAR-18 T3 7/200/135 STENT, SUPERFICIAL FEMORAL ARTERY NIP BIOTRONIK AG, BUELACH, SWITZERLAND 430516 09230341 07640130447141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization