BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT

    MDR report key: 21959731 · Received May 5, 2025

    Report

    Report Number
    3008114965-2025-00417
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 5, 2025
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRA
    UDI-DI
    10886704028888
    PMA / PMN Number
    K021591
    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. THE DEVICE WAS DISCARDED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. 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. CATHETER OBSTRUCTION IN PATIENT WITH LOSS OF CEREBRAL TARGET POSITION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE PROWLER SELECT PLUS MICROCATHETER. 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. 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. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. 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

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ENTERPRISE2 4MMX16MM INTRACRANIAL STENT (ENCR401612, 9080736) BECAME IMPEDED IN THE PROXIMAL OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR TRIED TO RETRACT THE STENT, THE STENT WAS FOUND DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER (MC). DOCTOR REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND SWITCHED TO A NEW STENT AND A NEW MICROCATHETER (BOTH WERE OTHER BRANDS) TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831245 PROWLER SELECT CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENTERPRISE2 4MMX16MM