BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 17027898 · Received May 30, 2023

    Report

    Report Number
    3008114965-2023-00303
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 11, 2023
    Report Date
    May 31, 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

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 31-MAY-2023. [ADDITIONAL INFORMATION]: ON 31-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOCATION OF THE TARGET ANEURYSM WAS NOT KNOWN; THE TARGET WAS AN UNRUPTURED ANEURYSM. THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE REPORTED ISSUE. THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. DURING ADVANCEMENT OF THE STENT, THERE WAS SOME RESISTANCE NOTED AT APPROXIMATELY 100CM FROM THE MICROCATHETER HUB. THE INCOMPLETE EXPANSION DID NOT RESULT IN STENT MIGRATION OR EMBOLIZATION OF THE STENT. ADEQUATE CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO VISIBLE KINKS OR OTHER DAMAGES OBSERVED ON THE MICROCATHETER. THE STENT COMPONENT WAS STILL ON THE DELIVERY WIRE WHEN IT WAS REMOVED FROM THE PATIENT. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGE. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE REPLACEMENT STENT AND THE REPLACEMENT MICROCATHETER WERE NOT THE SAME STENT AND THE SAME MICROCATHETER AS THE COMPLAINT DEVICES. THERE WAS NO PATIENT ADVERSE EVENT OR COMPLICATION. THE PHYSICIAN DID NOT CONSIDER THE 30-MINUTE EXTENSION OF THE PROCEDURE TO BE CLINICALLY SIGNIFICANT. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00302 AND 3008114965-2023-00303. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30887537) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. 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 ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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 AT A LATER TIME. 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 IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00302. 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. THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE COMPLAINT STENT, A 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC453712 / 7161632) WAS DELIVERED TO 2/3 OF THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30887537). AFTER THE STENT WAS PLACED IN THE TARGET POSITION, IT WAS FOUND THAT THE STENT TIP WAS UNABLE TO OPEN. THE PHYSICIAN RETRACTED THE STENT AND THE MICROCATHETER AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY STABLE. THE PROCEDURE WAS PROLONGED ABOUT 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682521 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 606-S255X 30887537 10886704028888

    Patients

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