BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 18307615 · Received December 11, 2023

    Report

    Report Number
    3008114965-2023-00897
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    October 8, 2022
    Report Date
    January 16, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 09-JAN-2024. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00896 AND 3008114965-2023-00897. 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, 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. SECTION H.3: 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. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30766811) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00896 AND 3008114965-2023-00897. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATION FINDING OF THE RETURNED DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. NO APPEARANCE OF DAMAGES WERE OBSERVED. MICROSCOPIC INSPECTION WAS PERFORMED ALONG THE BODY OF THE PROWLER, AND NO DAMAGES WERE FOUND. THE DEVICE WAS FLUSHED WITH A LABORATORY SAMPLE SYRINGE. AFTER FLUSHING, A LAB SAMPLE ENTERPRISE SYSTEM WAS INTRODUCED INTO THE RECEIVED MICROCATHETER AND WAS ABLE TO BE ADVANCED THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER WITHOUT NOTICEABLE RESISTANCE. THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) OF THE DEVICE WERE MEASURED AND CONFIRMED TO BE WITHIN SPECIFICATIONS. THE ENTERPRISE SYSTEM WAS ABLE TO PASS THROUGH THE ENTIRE LENGTH OF THE MICROCATHETER WITHOUT SIGNIFICANT RESISTANCE, THROUGH THE PROXIMAL PORTION. ADDITIONALLY, NO OTHER DAMAGES WERE FOUND ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE ISSUE REPORTED DURING THE PROCEDURE. THE REPORTED ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED WITH THE EVIDENCE AVAILABLE. IT IS POSSIBLE THAT OTHER CLINICAL AND PROCEDURAL FACTORS THAT CANNOT BE REPLICATED DURING THE ANALYSIS MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (30766811) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE INSTRUCTION FOR USE (IFU) CONTAINS 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. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.10. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00896 AND 3008114965-2023-00897. 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 AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452812 / 7002191) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30766811) AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT FROM THE PATIENT AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 30-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OF THE PROCEDURE WAS A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM IN A 65-YEAR-OLD FEMALE PATIENT. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS STILL ON THE DELIVERY WIRE. THE STENT WAS IMPEDED IN THE PROXIMAL SECTION OF THE MICROCATHETER. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452812) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE INFORMATION CONFIRMED THAT THERE WAS NO NEGATIVE PATIENT IMPACT. REGARDING THE 30-MINUTE PROCEDURE EXTENSION BEING CONSIDERED CLINICALLY SIGNIFICANT, THE INFORMATION COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214414 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINUOUS FLUSH KRA MEDOS INTERNATIONAL SARL 30766811 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female EU 4.5X28MM STENT 12 MM DW TIP