BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 16788371 · Received April 21, 2023

    Report

    Report Number
    3008114965-2023-00234
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    February 12, 2023
    Report Date
    April 21, 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). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, 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. 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. 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 ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW 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. CATHETER OBSTRUCTION DURING INTRACRANIAL VASCULAR STENT PLACEMENT AND LOSS OF MICROCATHETER TARGET POSITION IN THE INTRACRANIAL SETTING ARE KNOWN ISSUES. LOSS OF MICROCATHETER TARGET POSITION IN THE INTRACRANIAL VASCULATURE WILL REQUIRE RE-ACCESSING THE TARGET SITE WITH INCREASED POTENTIAL FOR VESSEL TRAUMA, VESSEL SPASM, AND/OR ISCHEMIA/INFARCT. THERE ARE CLINICAL AND PROCEDURAL FACTORS INCLUDING ANEURYSM/VESSEL CHARACTERISTICS (I.E., TORTUOSITY, STENOSIS), DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE THAT MAY HAVE CONTRIBUTED WITH NO INDICATION OF A DESIGN OR MANUFACTURING ISSUE, NEVERTHELESS, THE EVENT MEETS REPORTING CRITERIA AS A ¿MALFUNCTION¿ UNDER 21 CFR 803. MOREOVER, ALTHOUGH NOT REFERRED TO AS CLINICALLY SIGNIFICANT, THE REPORTED EVENT RESULTED IN THE PROLONGATION OF THE SURGICAL PROCEDURES. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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 NUMBER IS: 3008114965-2023-00233. 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. 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 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 ON (B)(6)2023, DURING A VASCULAR STENT PLACEMENT PROCEDURE TARGETING AN INTRACRANIAL STENOSIS, THE COMPLAINT STENT, A 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 7190236) WAS IMPEDED IN THE PROXIMAL SECTION OF THE COMPLAINT MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AND COULD NOT PASS THROUGH. THE PHYSICIAN RETRACTED THE MICROCATHETER AND THE STENT; BOTH WERE REPLACED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED ABOUT HALF AN HOUR. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 09-APR-2023, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOT NUMBER OF THE PROWLER SELECT PLUS MICROCATHETER WAS UNOBTAINABLE. ON 21-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ADEQUATE CONTINUOUS FLUSH WAS 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. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE LOT NUMBER OF THE COMPLAINT STENT WAS CONFIRMED TO BE 7190236. THE LOT NUMBER OF THE PROWLER SELECT PLUS MICROCATHETER IS NOT KNOWN. THE COMPLAINT STENT WAS REPLACED WITH ANOTHER 4MM X 23MM ENTERPRISE 2 OF THE SAME CATALOG NUMBER (ENCR402312). IT WAS NOT KNOWN IF THE REPLACEMENT MICROCATHETER WAS ANOTHER PROWLER SELECT PLUS. THERE WAS NO ALLEGATION OF PATIENT INJURY OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685239 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 606-S255X 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENTERPRISE2 4MMX23MM