BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 16983387 · Received May 23, 2023

    Report

    Report Number
    3008114965-2023-00333
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 12, 2023
    Report Date
    June 14, 2023
    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). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. SECTION E1. INITIAL REPORTER PHONE: (B)(6). SECTION H3 - 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. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2023-00332. 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). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN EU 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 7000288) BECAME IMPEDED IN DISTAL END OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 30909764) AND COULD NOT PASS THROUGH. THE PHYSICIAN STARTED TO RETRACT THE STENT, THE STENT DEPLOYED IN PROXIMAL OF THE MICROCATHETER PREMATURELY DURING WITHDRAWAL. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT¿S BODY AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE 150CM X 5CM PROWLER SELECT PLUS WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND NO APPARENT DAMAGE WAS NOTED. A MICROSCOPIC INSPECTION OF THE ENTIRE DEVICE'S LENGTH WAS PERFORMED, AND THE MICROCATHETER WAS FOUND UNDAMAGED (I.E., NO KINK, NO BENT OR COMPRESSED). 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 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 30909764 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. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO CAPA ACTIVITY IS REQUIRED. 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 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). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. 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 4.5X37MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC453712, 7000288) BECAME IMPEDED IN DISTAL END OF THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 30909764) AND COULD NOT PASS THROUGH. THE PHYSICIAN STARTED TO RETRACT THE STENT, THE STENT DEPLOYED IN PROXIMAL OF THE MICROCATHETER PREMATURELY DURING WITHDRAWAL. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT¿S BODY AND SWITCHED TO NEW DEVICES TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244355 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 606-S255X 30909764 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EU 4.5X37MM STENT 12 MM DW TIP