BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 1916983 · Received December 8, 2010

    Report

    Report Number
    1058196-2010-00366
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K993266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2010-00366 AND 1058196-2010-00367. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE PROWLER PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. IT WAS INSPECTED AND KINKS WERE FOUND ON IT. THE DISTAL BODY WAS INSPECTED AND SEVERAL COMPRESSED/FLAT SECTIONS WERE FOUND. HUB WAS INSPECTED AND NO ANOMALIES WERE FOUND. THE ID OF THE MICROCATHETER WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATION. THE DISTAL BODY OF THE MICROCATHETER WAS INSPECTED UNDER MICROSCOPE AND THE COMPRESSED/FLAT SECTIONS FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED. AN GUIDEWIRE .018 (CORDIS LAB SAMPLE), WAS INTRODUCED IN TO THE MICROCATHETER AND IT ADVANCE SMOOTHLY; HOWEVER IT WAS STUCK IN THE COMPRESSED SECTIONS FOUND IN THE DISTAL SECTION OF THE DEVICE, THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE THE CONDITIONS OF THE RECEIVED PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER AS 'CATHETER- OBSTRUCTED' WAS CONFIRMED DURING THE ANALYSIS, THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER WAS DUE TO THE COMPRESSED/FLAT SECTIONS FOUND IN THE MICROCATHETER, THE CAUSE OF THE COMPRESSED/FLAT SECTION COULD NOT BE CONCLUSIVELY DETERMINED; NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED OR THE COMPRESSED SECTION FOUND ON THE MICROCATHETER COULD BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KIND OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL FACTORS APPEAR TO BE CONTRIBUTED IN THE EVENT REPORTED AND THE DAMAGES FOUND; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF AN UNKNOWN TARGET SITE OR PROCEDURE TYPE, 2MMX5CM COILS (VORTEX, BOSTON SCIENTIFIC) WERE DELIVERED IN TWO PROWLER SELECT MICROCATHETERS (B)(4) USING BOSTON SCIENTIFIC COIL PUSHERS BUT THE COILS WERE STUCK IN THE PROWLER MICROCATHETERS. THE MICROCATHETERS WERE REMOVED AND ANOTHER NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. NO DAMAGES WERE NOTED ON THE MICROCATHETERS THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND THE MICROCATHETERS WERE FLUSHED AFTER EVERY COIL WAS DELIVERED. THERE WAS NO INFORMATION REGARDING THE VESSEL CHARACTERISTICS. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE PROWLER PLUS MICROCATHETER (MC) WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. IT WAS INSPECTED AND KINKS WERE FOUND ON IT. THE DISTAL BODY WAS INSPECTED AND SEVERAL COMPRESSED/FLAT SECTIONS WERE FOUND. HUB WAS INSPECTED AND NO ANOMALIES WERE FOUND. THE ID OF THE MC WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATION. THE DISTAL BODY OF THE MC WAS INSPECTED UNDER MICROSCOPE AND THE COMPRESSED/FLAT SECTIONS FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED. AN CORDIS LAB SAMPLE 0.018" GUIDEWIRE (GW), WAS INTRODUCED IN TO THE MC AND IT ADVANCE SMOOTHLY; HOWEVER IT WAS STUCK IN THE COMPRESSED SECTIONS FOUND IN THE DISTAL SECTION OF THE DEVICE. THE MC WAS CUT IN THE DISTAL AREA AND A PART OF THE EMBOLIC COIL (DETAIL UNKNOWN) WAS EXPOSED, THE PART OF THE EMBOLIC COIL WAS FOUND STUCK IN ONE OF THE SEVERAL COMPRESSED/FLAT SECTIONS FOUND IN THE DEVICE, THE PART OF THE EMBOLIC COIL WAS REMOVED FROM THE UNIT, AFTER THAT THE GW WAS INSERTED AGAIN FROM THE HUB AND EVEN THE DAMAGE PRESENTED ON THE DEVICE IN THIS NEW ATTEMPT THE GW COULD PASS THROUGH THE MC. RESIDUES OF DRY BLOOD WERE EXPELLED FROM THE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED OBSTRUCTION OF THE PROWLER SELECT MICROCATHETER WAS CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE REPORTED EVENT WAS DUE TO ONE EMBOLIC COIL (REPORTED AS A BOSTON SCIENTIFIC VORTEX) BEING STUCK IN THE DEVICE DUE TO THE COMPRESSED/FLAT SECTION. THE CAUSE OF THE KINKS AND COMPRESSED/FLAT SECTIONS COULD NOT BE CONCLUSIVELY DETERMINED. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES FROM LEAVING THE FACILITY. IN ADDITION, THE PRESENCE OF BLOOD IN THE CATHETER LUMEN MAY BE AN INDICATION THAT NOT MAINTAINING AN ADEQUATE CONTINUOUS FLUSH AS OUTLINED IN THE INSTRUCTIONS FOR USE MAY HAVE CONTRIBUTED TO THE EVENT. PROCEDURAL FACTORS AND INTERACTION WITH THE CONCOMITANT DEVICE APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT AND DAMAGES FOUND. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00366 AND 1058196-2010-00367.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13470905 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS OR EXCURSIONS WERE ISSUED FOR THIS LOT 13470905. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00366 AND 1058196-2010-00367. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF AN UNKNOWN TARGET SITE OR PROCEDURE TYPE, 2MMX5CM COILS (VORTEX, BOSTON SCIENTIFIC) WERE DELIVERED IN TWO MICROCATHETERS 606-2511 (COMPLAINT PRODUCTS) WITH THE COIL PUSHERS (DETAIL UNKNOWN, BOSTON SCIENTIFIC), BUT THE COILS WERE STUCK IN THE MICROCATHETERS. THE MICROCATHETERS WERE REMOVED AND THE ANOTHER NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. NO DAMAGES WERE NOTED ON THE MICROCATHETERS THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND THE MICROCATHETERS WERE FLUSHED AFTER EVERY COIL WAS DELIVERED. BOTH COILS WERE BOSTON SCIENTIFIC PRODUCTS. THERE WAS NO INFORMATION REGARDING THE VESSEL CHARACTERISTICS. NO ADDITIONAL INFORMATION IS AVAILABLE, AND THE PRODUCTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 13470905

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR NON-CORDIS COILS