BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2022364 · Received March 17, 2011

    Report

    Report Number
    1058196-2011-00106
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE PROWLER SELECT PLUS MICROCATHETER WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. AN ENTERPRISE WAS RECEIVED STUCK INSIDE OF THE MICROCATHETER. DEVICE PRESENTED COMPRESSED SECTIONS WERE NOTED ON DISTAL SHAFT. STENT WAS PROTRUDED 1MM FROM THE DISTAL END. THE DISTAL AREA OF THE MICROCATHETER WAS INSPECTED UNDER A LIGHT OPTICAL MICROSCOPE AND NO ANOMALIES WERE FOUND BESIDES OF THE DAMAGE OBSERVED DURING VISUAL ANALYSIS. THE FUNCTIONAL ANALYSIS WAS ATTEMPTED TO PERFORM AS RECEIVED THE DEVICES, BUT IT WAS NO POSSIBLE SINCE THE ENTERPRISE COULD NOT BE ADVANCE IN ANY DIRECTION INTO THE MICROCATHETER, THEREFORE THE PIECES STILL ASSEMBLED WAS CLEANED IN THE ULTRASONIC CLEANER. AFTER TO CLEAN THE DEVICE, ANOTHER TRY WAS PERFORMED TO ADVANCE THE ENTERPRISE INTO THE MICROCATHETER; THE STENT COULD BE DEPLOYED PARTIALLY, BUT DUE TO THE DAMAGES THE DELIVERY WIRE AND DRY BLOOD RESIDUES, IT COULD NOT ADVANCE MORE; THEREFORE THE STENT WAS REMOVED MANUALLY. THE DELIVERY WIRE (WITHOUT STENT) WAS INSERTED AND WITHDRAWAL IN THE MICROCATHETER AND NO DIFFICULTY WAS FELT DURING THE TEST. ADDITIONALLY AN ENTERPRISE CORDIS LAB SAMPLE WAS INTRODUCED IN TO THE MICROCATHETER AND RESISTANCE WAS EXPERIENCED WHEN THE STENT TRIED TO PASS THROUGH THE COMPRESSED SECTION. 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 15256938 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED FAILURE BY CUSTOMER AS "OBSTRUCTED" WAS CONFIRMED DUE THE RECEIVED CONDITION OF THE DEVICE. THE COMPRESSED SECTION NOTED IN THE DEVICE APPEARS TO BE CONTRIBUTED IN THE FAILURE EXPERIENCED BY THE CUSTOMER. THE EXACT CAUSE OF THIS EVENT AS WELL AS THE DAMAGE OBSERVE ON THE MICROCATHETER COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE ANALYSIS SUGGEST THAT PROCEDURALS/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THESE EVENTS. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MICROCATHETER PROCESS; IN ADDITION INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00106 AND 1058196-2011-00107. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING STENTING OF 7X4.5 WIDE NECKED ANEURYSM, THE ENTERPRISE STENT COULD NOT BE PUSHED OUT THE DISTAL TIP OF THE PROWLER SELECT PLUS MICROCATHETER. THE PHYSICIAN TRIED TO REPOSITION STENT SEVERAL TIMES BUT THAT WOULD NOT RESOLVE THE ISSUE, EVEN ON THE BACK TABLE AFTER REMOVAL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT OUT OF THE MICROCATHETER. AS A RESULT THE PHYSICIAN REMOVED THE ENTIRE SYSTEM AND ANOTHER ENTERPRISE 4.5X22 STENT WAS UTILIZED WITH SECONDARY PROWLER SELECT PLUS MICROCATHETER. SUBSEQUENTLY, 15 MICRO COILS WERE PLACED AND ANEURYSM, AND WAS COMPLETELY OBLITERATED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES DURING THE PROCEDURE, AND DURING INSERTION, NO RESISTANCE/FRICTION OCCURRED BETWEEN THE MICROCATHETER AND DELIVERY SYSTEM. DURING POSITIONING, THE MICROCATHETER WAS NOT PLACED AT AN ACUTE ANGLE OR WITHIN A SMALL BRANCH (PLACED OUT THE A1 BRANCH). THE MICROCATHETER WAS NOT RE-SHAPED. DURING INSERTION, THERE WAS NO DIFFICULTY INSERTING THE STENT IN THE HUB. THE INTRODUCER, DELIVERY SYSTEM OR STENT, WERE NOT DAMAGED DURING INSERTION. THE TARGET SITE WAS A SIDEWALL (ICA) INTERNAL CAROTID ARTERY AT THE PCOM WITH A NECK THAT MEASURE 4.5MM. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00106 AND 1058196-2011-00107. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00106 AND 1058196-2011-00107. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING TREATMENT OF A SIDEWALL INTERNAL CAROTID ARTERY ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY THE 22MM ENTERPRISE STENT COULD NOT BE PUSHED OUT THE DISTAL TIP OF THE PROWLER SELECT PLUS MICROCATHETER. ATTEMPT TO REPOSITION THE STENT SEVERAL TIMES DID NOT RESOLVE THE ISSUE. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. AFTER REMOVAL FROM THE PATIENT, THE STENT WAS UNABLE TO BE ADVANCED OUT OF THE MICROCATHETER. ANOTHER ENTERPRISE 4.5X22 STENT WAS UTILIZED WITH ANOTHER PROWLER SELECT PLUS AND SUBSEQUENTLY 15 MICRO-COILS WERE PLACED WITH COMPLETE OBLITERATION OF THE 7X4.5 ANEURYSM WHICH HAD A 4.5MM NECK. THE MICROCATHETER WAS NOT RESHAPED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES DURING THE PROCEDURE. THE MICROCATHETER WAS NOT AT AN ACUTE ANGLE OR WITHIN A SMALL BRANCH. THE DISTAL TIP WAS INITIALLY PLACED IN THE A1 BRANCH. THERE WAS NO DIFFICULTY INSERTING THE STENT INTO THE HUB OF THE MICROCATHETER. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE MICROCATHETER AND DELIVERY SYSTEM PRIOR TO THE EVENT. REVIEW OF PROWLER SELECT PLUS LOT 15256938 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED INABILITY TO ADVANCE THE ENTERPRISE VRD OUT OF THE DISTAL END OF THE PROWLER SELECT PLUS MICROCATHETER WAS CONFIRMED WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE. THE EXACT CAUSE OF THIS EVENT AS WELL AS THE DAMAGES OBSERVE ON THE DELIVERY WIRE NOT BE CONCLUSIVELY DETERMINED, HOWEVER THE ANALYSIS SUGGEST THAT PROCEDURAL/HANDLING FACTORS INCLUDING POSSIBLE INADEQUATE FLUSH AND COMPRESSIONS IN THE MICROCATHETER MAY HAVE CONTRIBUTED TO THESE EVENTS. THE DEVICES DID NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY CONTRIBUTING TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS OF THE ENTERPRISE, THE PROWLER SELECT PLUS NOR THE DHR REVIEWS SUGGESTS A RELATIONSHIP TO THE MANUFACTURING PROCESS OF EITHER DEVICE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00106 AND 1058196-2011-00107.

    Description of Event or Problem · 1

    DURING STENTING OF A 7X4.5 WIDE NECKED ANEURYSM, ENTERPRISE STENT COULD NOT BE PUSHED OUT THE DISTAL TIP OF THE PROWLER SELECT PLUS MICROCATHETER. PHYSICIAN TRIED TO REPOSITION STENT SEVERAL TIMES BUT THAT WOULD NOT RESOLVE THE ISSUE. EVEN ON THE BACK TABLE AFTER REMOVAL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE STENT OUT OF THE MICROCATHETER. AS A RESULT THE PHYSICIAN REMOVED THE ENTIRE SYSTEM AND OPENED/USED ANOTHER PROWLER SELECT/ENTERPRISE. ENTERPRISE VRD AND DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15256938

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR ENTERPRISE VRD