BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2494185 · Received March 16, 2012

    Report

    Report Number
    1058196-2012-00120
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 23, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2012-00119 AND #1058196-2012-00120.

    Additional Manufacturer Narrative · 1

    DURING A STENT ASSISTED COIL EMBOLIZATION, THE ENTERPRISE VRD AND DELIVERY SYSTEM WAS NOT ABLE TO BE ADVANCED THROUGH THE PROWLER SELECT PLUS MICROCATHETER (MC). THERE WAS NO REPORTED PRODUCT ISSUE WITH THE MC; HOWEVER THERE WAS REPORTED LOSS OF ACCESS TO THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING SIMILAR/LIKE PRODUCTS. THE TARGET LESION WAS AN ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. NO TARGET LESION/ANEURYSM MEASUREMENT INFORMATION WAS AVAILABLE. AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MICRO-CATHETER AT ALL TIMES. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4): THE PROWLER SELECT PLUS MC WAS NOT RECEIVED FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. PROCEDURALLY, THE MC WOULD HAVE BEEN PLACED AT THE TARGET SITE OVER A GUIDEWIRE; THEREFORE, IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE INABILITY TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MC. WITHOUT THE RETURN OF THE MC FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH FUNCTIONAL TESTING THERE WAS NO DIFFICULTY ADVANCING THE RETURNED ENTERPRISE THROUGH A LAB SAMPLE MC. THE CONCOMITANT MC WAS NOT RETURNED FOR ANALYSIS; HOWEVER, PROCEDURALLY THE MC WOULD HAVE BEEN PLACED AT THE TARGET SITE OVER A GUIDEWIRE; THEREFORE, BASED ON THE ANALYSIS OF THE RETURNED ENTERPRISE SYSTEM AND THE LIMITED AVAILABLE INFORMATION, IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE INABILITY TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MC. THERE IS NO INDICATION OF ANY MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE ENTERPRISE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2012-00119 AND #1058196-2012-00120.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A STENT ASSISTED COIL EMBOLIZATION, THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE ENTERPRISE VRD AND DELIVERY SYSTEM THROUGH THE PROWLER SELECT PLUS MICROCATHETER (MC). THERE WAS NO REPORTED PRODUCT ISSUE WITH THE MC, HOWEVER THERE WAS REPORTED LOSS OF ACCESS TO THE TARGET LESION. THE TARGET LESION WAS AN ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM. NO TARGET LESION/ANEURYSM MEASUREMENT INFORMATION WAS AVAILABLE. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY USING SIMILAR/LIKE PRODUCTS. THERE WAS NO REPORTED PATIENT INJURY. AN ADEQUATE/CONTINUOUS FLUSH WAS MAINTAINED TO THE MICRO-CATHETER AT ALL TIMES. THE PRODUCTS WERE INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCTS WERE PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE VRD AND DELIVERY