BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 15725859 · Received November 4, 2022

    Report

    Report Number
    3008114965-2022-00719
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 24, 2022
    Report Date
    December 7, 2022
    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

    PRODUCT COMPLAINT # (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 6812660) BECAME IMPEDED IN A PROWLER SELECT PLUS 150/5CM (606S255X, 30654776) MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE PHYSICIAN RETRACTED THE STENT AND MICROCATHETER AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RESISTANCE WAS FELT AT THE BODY/SHAFT OF THE DEVICE. THE MC DID NOT BECOME KINKED PRIOR TO THE ENCOUNTERED RESISTANCE. NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE REPLACEMENT STENT WAS OF THE SAME SIZE AS THE ORIGINAL ONE (4.5MM X 22MM). ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WERE NO PROCEDURAL DELAYS DUE TO THE VENT. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE PROWLER SELECT PLUS 150/5CM WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND NO APPARENT DAMAGE WAS OBSERVED. A MICROSCOPIC INSPECTION OF THE ENTIRE DEVICE'S LENGTH WAS PERFORMED, AND NO ADDITIONAL DAMAGES WERE FOUND. THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) WERE MEASURED, AND THEY WERE FOUND TO BE WITHIN SPECIFICATIONS. THE DEVICE WAS FLUSHED WITH A LABORATORY SAMPLE SYRINGE. AFTER THAT, A .018-INCH LAB SAMPLE GUIDEWIRE WAS INSERTED INTO THE RECEIVED MICROCATHETER. THE GUIDEWIRE COULD BE ADVANCED UNTIL IT CAME OUT FROM THE DISTAL TIP OF THE MICROCATHETER WITHOUT NOTICEABLE RESISTANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30654776 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. ALTHOUGH THE FUNCTIONAL TEST COULD NOT BE PERFORMED WITH THE INVOLVED ENTERPRISE SYSTEM, THE GUIDEWIRE BEING ABLE TO PASS THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER INDICATED THAT IT WAS NOT OBSTRUCTED. ADDITIONALLY, NO DAMAGES WERE FOUND ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE ISSUE ENCOUNTERED DURING THE PROCEDURE. OTHER CIRCUMSTANCES OR PROBLEMS MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THEREFORE, THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. 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 CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 3008114965-2022-00718. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 6812660) BECAME IMPEDED IN A PROWLER SELECT PLUS 150/5CM (606S255X, 30654776) MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE PHYSICIAN RETRACTED THE STENT AND MICROCATHETER AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RESISTANCE WAS FELT AT THE BODY/SHAFT OF THE DEVICE. THE MC DID NOT BECOME KINKED PRIOR TO THE ENCOUNTERED RESISTANCE. NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE REPLACEMENT STENT WAS OF THE SAME SIZE AS THE ORIGINAL ONE (4.5MM X 22MM). ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WERE NO PROCEDURAL DELAYS DUE TO THE VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521319 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 606-S255X 30654776 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EU 4.5X22MM STENT 12 MM DW TIP.