BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT

    MDR report key: 23027265 · Received September 11, 2025

    Report

    Report Number
    3008114965-2025-00978
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 11, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    QJP
    UDI-DI
    10886704028888
    PMA / PMN Number
    K210838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. SECTION H4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE REPORTED FAILURE COULD NOT BE EVALUATED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THERE ARE CIRCUMSTANCES OF THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING CAUTION: ¿IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE AS A SYSTEM. WARNING: NEVER ADVANCE OR WITHDRAW AN INTRALUMINAL DEVICE AGAINST RESISTANCE. MOVEMENT OR FORCE OF CATHETER OR GUIDE WIRE AGAINST RESISTANCE COULD DISLODGE A CLOT, PERFORATE A VESSEL WALL, OR SEVERELY DAMAGE THE CATHETER AND/OR GUIDE WIRE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A 4.5MMD X 28MML ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452812, 9080734) WAS IMPEDED WHEN THE STENT PASSED A PROWLER SELECT PLUS 150/5CM MICROCATHETER TIP (606S255X, LOT UNKNOWN) A SHORT SECTION, AND COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE STENT INTO THE MICROCATHETER (MC) AND DELIVERED IT AGAIN, THE STENT HAD THE SAME ISSUE. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT, THEN SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. ADDITIONAL EVENT INFORMATION RECEIVED ON 11-SEP-2025 INDICATED THAT NO DEVICE WAS USED TO APPLY TORQUE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINUTES PROCEDURAL PROLONGATION DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2709039 PROWLER SELECT CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDOS INTERNATIONAL SARL 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EU 4.5X28MM STENT 12 MM DW TIP