BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT PLUS 150/5CM

    MDR report key: 7549633 · Received May 29, 2018

    Report

    Report Number
    1226348-2018-00595
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 2, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC (MEXICO)
    Product Code
    KRA
    UDI-DI
    10886704028888
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, THE PULSERIDER T, 3 MM, 10 MM ARCH (211D / W3119-08) WOULD NOT ADVANCE INTO THE PROWLER SELECT PLUS MICROCATHETER (606S255X / 30006959). THERE WAS NO KINK OR BENT OBSERVED ON THE MICROCATHETER. THE PHYSICIAN REMOVED AND SWITCHED THE PROWLER SELECT PLUS MICROCATHETER FOR A NEW MICROCATHETER AND THE PULSERIDER DEVICE WOULD NOT ADVANCE INTO THE NEW MICROCATHETER. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR COMPLICATION. THE REPORTED EVENT RESULTED IN A 10- MINUTE DELAY IN THE PROCEDURE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED. INVESTIGATION SUMMARY: A NON-STERILE PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED COILED IN A POUCH. THE DEVICE WAS INSPECTED; THERE WAS DRY BLOOD RESIDUES OBSERVED ON THE HUB BUT NO DAMAGES WERE NOTED ON THE DEVICE. THE INNER DIAMETER (ID) OF THE MICROCATHETER WAS MEASURED AND WAS CONFIRMED TO BE WITHIN SPECIFICATIONS. THE HUB ID 0.021¿; SPECIFICATION: 0.021" MINIMUM. THE DISTAL ID 0.021¿; SPECIFICATION: 0.021" MINIMUM. THE RECEIVED MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE. A .018¿ LAB SAMPLE GUIDEWIRE WAS INTRODUCED INTO THE MICROCATHETER. THE GUIDEWIRE WAS ABLE TO ADVANCE TO THE DISTAL TIP WITHOUT ANY ISSUE. THE REPORTED ISSUE OF THE MICROCATHETER BEING OBSTRUCTED WAS NOT CONFIRMED DURING THE PRODUCT FUNCTIONAL ANALYSIS. DEVICE HISTORY LOT: A MANUFACTURING REVIEW OF THE LOT 30006959 WAS PERFORMED. IT WAS NOTED THAT ONE UNIT WAS REJECTED DUE TO THE DEFECT SCRUNCH AND 1 UNIT WAS REJECTED FOR THE DEFECT OF SMALL INNER DIAMETER. THIS COULD BE RELATED TO THE REPORTED COMPLAINT; HOWEVER, THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED TO BE POTENTIALLY RELATED TO THE REPORTED COMPLAINT. 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. 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 · 1

    (B)(4). INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. CONCOMITANT MED PRODUCTS: PULSERIDER T, 3 MM, 10 MM ARCH (211D / W3119-08). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 1226348-2018-00595 AND 3008680601-2018-00545. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING THE MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, THE PULSERIDER T, 3 MM, 10 MM ARCH (211D / W3119-08) WOULD NOT ADVANCE INTO THE PROWLER SELECT PLUS MICROCATHETER (606S255X / 30006959). THERE WAS NO KINK OR BENT OBSERVED ON THE MICROCATHETER. THE PHYSICIAN REMOVED AND SWITCHED THE PROWLER SELECT PLUS MICROCATHETER FOR A NEW MICROCATHETER AND THE PULSERIDER DEVICE WOULD NOT ADVANCE INTO THE NEW MICROCATHETER. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR COMPLICATION. THE REPORTED EVENT RESULTED IN A 10- MINUTE DELAY IN THE PROCEDURE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392114 PROWLER SELECT PLUS 150/5CM CATHETER, CONTINOUS FLUSH KRA CODMAN AND SHURTLEFF, INC (MEXICO) 30006959 10886704028888

    Patients

    Seq Age Sex Outcome Treatment
    1