BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2082238 · Received May 9, 2011

    Report

    Report Number
    1058196-2011-00215
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    January 13, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE STENT VIA THE SELECT PLUS 150/5 CM (MC) MICROCATHETER, BUT DURING THE OPERATION, THE PHYSICIAN FOUND RESISTANCE AND IT WAS DIFFICULT TO ADVANCE THE ENTERPRISE VRD (ENC452812) THROUGH THE DISTAL END OF THE MICROCATHETER. ADDITIONALLY, THE ENTERPRISE SYSTEM WAS DIFFICULT TO WITHDRAW, AND BOTH UNITS WERE WITHDRAWN, AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED WITH THE DEVICES AT ALL TIMES. NO DAMAGES WERE NOTICED IN THE DISTAL SECTION OF THE MICROCATHETER. ADDITIONALLY, THE MICROCATHETER WAS NOT RE-SHAPED. DURING THE EVENT, NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED IN AN ATTEMPT TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MICROCATHETER. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE MICROCATHETER, ENTERPRISE SYSTEM OR STENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00214 & 1058196-2011-00215. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED INSIDE OF A PLASTIC BAG. COMPRESSES AND FLAT SECTION WERE NOTED ON THE MICROCATHETER'S SHAFT. NO OTHER ANOMALIES WERE NOTED. THE ID OF THE MICROCATHETER WAS MEASURED AND ACCORDING TO THE DRAWING (B)(4) WAS WITHIN SPECIFICATION. RECEIVED MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE; THEN A CORDIS/CODMAN GUIDEWIRE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCED THROUGH THE INNER LUMEN UNTIL THE DISTAL END BUT RESISTANCE WAS EXPERIENCED DUE TO THE FLATTENED AND COMPRESSED SECTIONS. AFTER THAT AN ENTERPRISE CORDIS/CODMAN LAB SAMPLES WAS TRIED TO INSERT, HOWEVER, THE STENT STUCK IN THE FLATTENED SECTION LOCATED NEAR TO THE HUB. 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 15160476 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FAILURE REPORTED BY THE CUSTOMER AS ''OBSTRUCTED IN PATIENT'' WAS CONFIRMED DURING THE FUNCTIONAL TEST. THE CAUSE OF THE OBSTRUCTION DURING THE FUNCTIONAL TEST WAS THE FLATTENED SECTION; HOWEVER THE CAUSE OF THE OBSTRUCTION EXPERIENCED BY THE CUSTOMER IN THE DISTAL SECTION APPEARS TO BE THE KINKS NOTED IN THE MICROCATHETER'S DISTAL SHAFT. THE CAUSE OF THE KINKS AND FLATTENED SECTIONS NOTED IN THE DEVICE APPEARS TO BE PROCEDURAL AND HANDLING RELATED DUE TO PER CH&SS INVESTIGATION THE CUSTOMER DOES NOT REPORT DAMAGES ON THE MICROCATHETER BEFORE USE. IN ADDITION INSPECTIONS ARE IN THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT MANUFACTURING FACTORS COULD BE CONTRIBUTED TO THESE DAMAGES. PROCEDURAL HANDLING APPEARS TO BE CONTRIBUTED IN THE FAILURE EXPERIENCED BY THE CUSTOMER; THEREFORE, NO CORRECTIVE ACTIONS 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 1058196-2011-00214 & 1058196-2011-00215. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED SATES THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE THE MICRO CATHETER SELECT PLUS WAS OBSTRUCTED IN THE PATIENT AND THE ENTERPRISE STENT MICRO WIRE WAS IMPEDED. DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE STENT VIA THE SELECT PLUS 150/5 CM (MC) MICROCATHETER, BUT DURING THE OPERATION, THE PHYSICIAN FOUND RESISTANCE AND IT WAS DIFFICULT TO ADVANCE THE ENTERPRISE VRD ((B)(4)) THROUGH THE DISTAL END OF THE MICROCATHETER. ADDITIONALLY, THE ENTERPRISE SYSTEM WAS DIFFICULT TO WITHDRAW, AND BOTH UNITS WERE WITHDRAWN, AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED WITH THE DEVICES AT ALL TIMES. NO DAMAGES WERE NOTICED IN THE DISTAL SECTION OF THE MICROCATHETER. ADDITIONALLY, THE MICROCATHETER WAS NOT RE-SHAPED. DURING THE EVENT, NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED IN AN ATTEMPT TO ADVANCE THE ENTERPRISE SYSTEM THROUGH THE MICROCATHETER. AFTER REMOVAL, OTHER THAN THE REPORTED EVENT, NO DAMAGES WERE NOTICED ON THE MICROCATHETER, ENTERPRISE SYSTEM OR STENT. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED INSIDE OF A PLASTIC BAG. COMPRESSES AND FLAT SECTION WERE NOTED ON THE MICROCATHETER'S SHAFT. NO OTHER ANOMALIES WERE NOTED. THE ID OF THE MICROCATHETER WAS MEASURED AND ACCORDING TO THE DRAWING (B)(4) WAS WITHIN SPECIFICATION. RECEIVED MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE; THEN A CORDIS/CODMAN GUIDEWIRE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCED THROUGH THE INNER LUMEN UNTIL THE DISTAL END BUT RESISTANCE WAS EXPERIENCED DUE TO THE FLATTENED AND COMPRESSED SECTIONS. AFTER THAT AN ENTERPRISE CORDIS/CODMAN LAB SAMPLES WAS TRIED TO INSERT, HOWEVER THE STENT STUCK IN THE FLATTENED SECTION LOCATED NEAR TO THE HUB. 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 15160476 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. FAILURE REPORTED BY THE CUSTOMER AS "OBSTRUCTED IN PATIENT" WAS CONFIRMED DURING THE FUNCTIONAL TEST. THE CAUSE OF THE OBSTRUCTION DURING THE FUNCTIONAL TEST WAS THE FLATTENED SECTION; HOWEVER THE CAUSE OF THE OBSTRUCTION EXPERIENCED BY THE CUSTOMER IN THE DISTAL SECTION APPEARS TO BE THE KINKS NOTED IN THE MICROCATHETER'S DISTAL SHAFT. THE CAUSE OF THE KINKS AND FLATTENED SECTIONS NOTED IN THE DEVICE APPEARS TO BE PROCEDURAL AND HANDLING RELATED DUE TO PER (B)(4) INVESTIGATION THE CUSTOMER DOES NOT REPORT DAMAGES ON THE MICROCATHETER BEFORE USE. IN ADDITION INSPECTIONS ARE IN PLACE ((B)(4)) THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT MANUFACTURING FACTORS COULD BE CONTRIBUTED TO THESE DAMAGES. PROCEDURAL HANDLING APPEARS TO BE CONTRIBUTED IN THE FAILURE EXPERIENCED BY THE CUSTOMER; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPLAINT OF SELECT PLUS MICRO CATHETER OBSTRUCTED WAS CONFIRMED ON ANALYSIS AND RELATED TO SEVERAL KINKS AND FLATTENED SPOT ON THE CATHETER. THE COMPLAINT OF ENTERPRISE IMPEDED WAS NOT CONFIRMED ON ANALYSIS; ALTHOUGH, THERE WAS SOME RESISTANCE WHEN THE DEVICE REACHED THE KINKED SECTION OF THE MICROCATHETER, THE DEVICE WAS ABLE TO PASS THROUGH THE ENTIRE LENGTH SUCCESSFULLY. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL COMPOSITION AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED AND CONFIRMED COMPLAINTS. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00214 & 1058196-2011-00215.

    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 15160476 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS OR EXCURSIONS WERE ISSUED FOR THIS LOT 15160476. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00214 AND 1058196-2011-00215. THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED THE STENT VIA THE SELECT PLUS 150/5 CM (MC) MICROCATHETER, BUT FOUND THAT IT WAS DIFFICULT TO CROSS, AND ALSO DIFFICULTY TO WITHDRAW THE ENTERPRISE VRD (ENC452812). THEN, WITHDREW THE ENTERPRISE WITH THE MC, AND CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15160476

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE VRD