BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT

    MDR report key: 24803650 · Received April 7, 2026

    Report

    Report Number
    3008114965-2026-00488
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 7, 2026
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    QJP
    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¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE FULL UDI IS NOT AVAILABLE WITHOUT THE EXPIRATION DATE. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED PRODUCT ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE (ENC452212 / 9872895) WAS IMPEDED IN THE DISTAL END OF THE ASSOCIATED 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN TRIED TO RETRACT THE STENT, BUT IT WAS FOUND THAT THE STENT COULD NOT BE RETRACTED. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT TOGETHER FROM THE PATIENT, THEN RETRACTED THE STENT AGAIN. THE STENT COMPONENT WAS DETACHED FROM THE DELIVERY WIRE AFTER IT WAS OUT OF THE MICROCATHETER. THE PHYSICIAN REPLACED THE STENT WITH ANOTHER 4.5MM X 22MM ENTERPRISE (ENC452212) AND REPLACED THE MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT.-WAS THE REPLACEMENT STENT ENTERPRISE1, ENTERPRISE2 OR IS IT ANOTHER BRAND?-ENTERPRISE1 OF SAME PRODUCT CODE. ON 02-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE VERTEBRAL ARTERY. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED ON THE STENT / STENT DELIVERY SYSTEM ASIDE FROM THE REPORTED PREMATURE DETACHMENT. THERE WAS NO DAMAGE NOTED ON THE ASSOCIATED MICROCATHETER. THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE IMPACT AND NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857727 PROWLER SELECT CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown