BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 2096874 · Received May 20, 2011

    Report

    Report Number
    1058196-2011-00246
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 11, 2011
    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

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WIHTIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING USE OF A PROWLER PLUS 150/50/45CM 1MB MICROCATHETER ((B)(4)) FOR AN ARTERIAL INFUSION THERAPY FOR THE MAXILLARY ARTERY, A SOUND LIKE AIR LEAKAGE WAS NOTED AND IT WAS NOTED THAT THE MICROCATHETER WAS DAMAGED. THE HUB WAS NOT CRACKED AND THE HUB WAS CONNECTED PROPERLY TO THE Y/TOUHY CONNECTOR. PRIOR TO THE EVENT A 5 FRENCH ENVOY (CAT # UNKNOWN) WAS ADVANCED FROM RIGHT FEMORAL ARTERY AND A SYNCHRO 14 (BOSTON SCIENTIFIC) GUIDEWIRE WAS USED. AFTER THE EVENT, THE MICROCATHETER WAS CHANGED TO OTHER NEW PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THERE WAS NO INFORMATION PROVIDED ABOUT THE TARGET VESSEL. THERE IS NO FURTHER INFORMATION AS TO WHETHER THERE WAS AN AIR LEAK, WHAT TYPE OF DAMAGE WAS NOTED ON THE MICROCATHETER, OR WHETHER THERE WAS ANY RESISTANCE AT ANYTIME DURING USE OF THE MICROCATHETER. NO FURTHER INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FOR INSPECTION. ONE NON-STERILE PROWLER PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. SEVERAL COMPRESSED SECTIONS WERE NOTED IN THE DISTAL SHAFT. SOME WAVES WERE NOTED IN THE DEVICE; HOWEVER THESE APPEAR TO OCCUR DURING THE HANDLING OF THE UNIT WHEN IT WAS RETURNED FOR EVALUATION. NO OTHER DAMAGES WERE NOTED. A CORDIS/CODMAN LAB SAMPLE SYRINGE WAS CONNECTED TO THE MICROCATHETER'S HUB AND THEN PRESSURE WAS APPLIED AND NO LEAKAGE WAS NOTED IN THE HUB. FLOW OF WATER WAS NOTED BY THE DISTAL END AND NO LEAKAGE WAS NOTED 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. REVIEW OF LOT 15115031 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ANALYSIS OF THE RETURNED DEVICE FOUND COMPRESSED AREAS AND WAVY APPEARANCE OF THE CATHETER. THERE WERE NO LEAKAGES IN THE CATHETER WITH FUNCTIONAL ANALYSIS. THE CAUSE OF THE DAMAGES NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGEST THAT THESE DAMAGE COULD BE OCCUR DURING THE MANUFACTURING PROCESS. IN ADDITION INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES LEAVING FROM THE FACILITY. ALTHOUGH BASED ON THE LIMITED AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE; BASED ON THE ANALYSIS, IT APPEARS THAT PROCEDURAL FACTORS, POSSIBLY CONCOMITANT DEVICES/CONNECTIONS MAY HAVE CONTRIBUTED IN THE REPORTED EVENT. THERE IS NO INDICATION OF ANY CONTRIBUTING DEVICE MANUFACTURING OR PERFORMANCE ISSUES. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING AN ARTERIAL INFUSION THERAPY FOR MAXILLARY ARTERY, THE PROWLER PLUS 150/50/45CM 1MB MICROCATHETER (606-2511, COMPLAINT PRODUCT) AND GUIDEWIRE (SYNCHRO14, BOSTON SCIENTIFIC) WERE USED FOR THE PROCEDURE, AND THERE MIGHT HAVE BEEN AIR LEAKAGE WAS NOTED, AND THE MICROCATHETER WAS DAMAGED. HOWEVER, THE HUB WAS NOT CRACKED, AND THE HUB WAS CONNECTED PROPERLY TO THE Y/TOUHY CONNECTOR. PRIOR TO THE EVENT, A 5FRENCH ENVOY (CAT # UNKNOWN) WAS ADVANCED FROM RIGHT FEMORAL ARTERY. AFTER THE EVENT, THE MICROCATHETER WAS CHANGED TO OTHER NEW PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THERE WAS NO INFORMATION PROVIDED ABOUT THE TARGET VESSEL. NO FURTHER INFORMATION WAS AVAILABLE. 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 15115031 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING AN ARTERIAL INFUSION THERAPY PROCEDURE, AIR LEAKAGE AND DAMAGED WAS NOTED IN THE PROWLER PLUS 150/50/45CM 1MB MICROCATHETER (606-2511). THE HUB WAS NOT CRACKED, AND THE HUB WAS CONNECTED PROPERLY TO THE Y OR TOUHY. THE MICROCATHETER WAS INSERTED VIA A 5FREMCH ENVOY (CAT # UNKNOWN) AND A GUIDEWIRE (SYNCHRO14, BOSTON SCIENTIFIC) FROM THE RIGHT FEMORAL ARTERY. THE MICROCATHETER WAS CHANGED TO OTHER NEW PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE TARGET SITE WAS THE MAXILLARY ARTERY. NO INFORMATION WAS PROVIDED ABOUT THE TARGET VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15115031

    Patients

    Seq Age Sex Outcome Treatment
    1 5F ENVOY CATHETER AND SYNCHRO14 GUIDEWIRE.