BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2072181 · Received April 28, 2011

    Report

    Report Number
    1058196-2011-00184
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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 (B)(4) AND 1058196-2011-00184. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT

    Additional Manufacturer Narrative · 1

    DURING TREATMENT FOR BASILAR ARTERY ANEURYSM, THE 7X21 COMPLEX FILL ORBIT COIL ((B)(4)/ LOT# 15217435) UNRAVELED IN THE PATIENT. WHEN USING A PALMAZ GENESIS ON AMIA (SDS RX GEN. AMIA 5.0X15 142CM) TO JAIL THE COIL AGAINST THE VESSEL, RESISTANCE WAS ENCOUNTERED WITH A 0.014 TRANSEND EX GUIDEWIRE GW AND THE PALMAZ DELIVERY SYSTEM PRIOR TO INSERTION INTO THE PATIENT. AFTER REMOVAL OF THE GW, A PIECE/FRAGMENT WAS FOUND WHICH INITIALLY WAS THOUGHT TO BE PART OF THE GW SINCE NO DAMAGE WAS FOUND WITH INSPECTION OF THE PALMAZ GENESIS SYSTEM. HOWEVER, AFTER SUCCESSFUL PLACEMENT OF THE PALMAZ GENESIS OVER AN ASAHI CHIKAI/ASAHI INTECC GW AT THE OSTIAL OF LEFT VERTEBRAL ARTERY, WITH INSPECTION OF THE PALMAZ GENESIS DELIVERY SYSTEM IT SEEMED THAT THE FRAGMENT COULD BE THE DISTAL TIP OF THE PALMAZ GENESIS DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THERE IS NO FURTHER CLINICAL OR PROCEDURAL INFORMATION PERTAINING TO THE USE OF OR THE REPORTED STRETCHING OF THE ORBIT COIL. PRIOR TO INSERTING THE GW, THE PALMAZ GENESIS DELIVERY SYSTEM WAS FLUSHED WITH HEPARINIZED SALINE. PRIOR TO INSERTION INTO THE PATIENT RESISTANCE/FRICTION WAS ENCOUNTERED WITH THE PALMAZ GENESIS DELIVERY SYSTEM AND A 0.014 TRANSEND EX GUIDEWIRE (GW) BOTH DURING INSERTION OF THE GW. THEREFORE, THE GW WAS REMOVED WITH RESISTANCE ALSO ENCOUNTERED DURING WITHDRAWAL. WHEN WIPING THE GW, A PIECE OF FRAGMENT WAS FOUND. IT IS UNKNOWN IF ADDITIONAL FORCE WAS UTILIZED TO REMOVE THE GW FROM THE PALMAZ DELIVERY SYSTEM OR IF THE DEVICE WAS WIPED DOWN PRIOR TO USE. THE TRANSEND EX GW WAS DISCARDED AT THE HOSPITAL. THE ORBIT DELIVERY WIRE IS NOT AVAILABLE FOR ANALYSIS. A NON STERILE PALMAZ GENESIS ON AMIA DELIVERY SYSTEM (SDS RX GEN. AMIA 5.0X15 142CM) WAS RECEIVED COILED INSIDE A POUCH. IT COMES WITH AN UNKNOWN GUIDE WIRE INSERTED IN THE CATHETER. BASED ON THE REPORTED INFORMATION, THIS WAS NOT THE GUIDE WIRE WITH WHICH RESISTANCE WAS ENCOUNTERED DURING INSERTION INTO THE DELIVERY SYSTEM. IN ADDITION, THE CATHETER APPEARS TO HAVE CRYSTALLIZED CONTRAST MEDIUM ALL OVER (INNER AND OUTER BODY, BALLOON, ETC). THE BALLOON APPEARS TO HAVE BEEN INFLATED AND DEFLATED. INSIDE THE SAME POUCH, A COTTON PIECE THAT CONTAINS WHAT SEEMS TO BE PART OF THE CATHETER'S TIP WAS FOUNDED. THE RECEIVED GUIDE WIRE WAS MEASURED WITH A LASER MICROMETER ACCORDING TO PROCEDURE; THE MEASUREMENT WAS (0.0129") WHICH IS WITHIN THE SPECIFIED GUIDE WIRE OD FOR USE WITH THE STENT DELIVERY SYSTEM (0.014"). IN ADDITION A CORDIS ATW 0.014" GUIDE WIRE WAS INTRODUCED THROUGH THE CATHETER, IN ORDER TO VERIFY DISTAL TIP ID/INNER LUMEN ID, OBTAINING CORRECT RESULTS AS IN SPECIFICATIONS. DUE TO THE CONDITIONS OF THE RETURNED NONCORDIS GUIDE WIRE FUNCTIONAL TESTING WAS DONE WITH A LAB SAMPLE CORDIS ATW 0.014- GUIDEWIRE; THERE WAS NO RESISTANCE WITH ADVANCEMENT THROUGH THE CATHETER. SEM ANALYSIS OF THE PALMAZ GENESIS ON AMIA DELIVERY SYSTEM TIP WAS PERFORMED. THE RESULTS SHOWED THAT TIP ELONGATIONS CAN BE OBSERVED THROUGH THE WHOLE CIRCUMFERENCE OF THE TIP, WHICH SUGGEST POSSIBLE STRETCHING. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION WAS NOTED. CUTTING WAS DISCARDED AS A FAILURE CAUSE SINCE NO MECHANICAL SURFACE DAMAGE WAS OBSERVED. THE EXACT CAUSE OF THIS SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED. 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 15206977 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CONTROLS IN PLACE: THERE IS A 100% INSPECTION TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. RESISTANCE WITH INSERTION OF A LAB SAMPLE GUIDEWIRE WAS NOT CONFIRMED. THE DISTAL TIP SEPARATED FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. ALTHOUGH, THE EXACT CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED; BASED ON THE ELONGATIONS OF THE SEPARATED TIP OF THE DEVICE FOUND DURING THE SEM ANALYSIS, IT APPEARS THAT PULLING FORCES CONTRIBUTED TO THE TIP SEPARATION. IT POSSIBLE THAT FACTORS ASSOCIATED WITH THE INITIAL NONCORDIS GUIDEWIRE/DEVICE INTERACTION CONTRIBUTING TO THE RESISTANCE/FRICTION MAY HAVE THEN CONTRIBUTED TO THE DISTAL TIP SEPARATION. WITH REVIEW OF THE RETURNED DEVICE AND THE MANUFACTURING RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES IMPACTING THE EVENTS. 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 616099-2011-00286 AND 1058196-2011-00184.

    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 15217435 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT (B)(4) AND 1058196-2011-00184. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TRANSEND GUIDEWIRES, ORBIT COIL AND AMIIA STENT. THE TARGET LESION FOR THE STENT PLACEMENT WAS OSTIAL OF LEFT VERTEBRAL ARTERY WITH NO CALCIFICATION OR VESSEL TORTUOSITY, AND THE RATE OF STENOSIS WAS 0%. PRIOR TO INSERTING THE GUIDEWIRE, THE GUIDEWIRE LUMEN WAS FLUSH WITH HEPARINIZED SALINE, AND AFTER RESISTANCE WAS EXPERIENCED, THE GW WAS REMOVED FROM THE PALMAZ GENESIS. WHEN THE GW WAS WIPED OFF, A PIECE OF FRAGMENT WAS FOUND. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE. ADDITIONAL INFORMATION IS EXPECTED. 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 15206977 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15206977. CATH. ASSY AMIIA SUBASSEMBLY LOT 15205645 WAS REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. PLEASE NOTE: THE CATALOG AND LOT NUMBER/(S) FOR THE ACTUAL PRODUCT/(S) USED IN THE PROCEDURE ARE UNKNOWN. AN INVESTIGATION IS IN PROCESS TO RETRIEVE THIS INFORMATION. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 616099-2011-00286 AND 1058196-2011-00184. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING TREATMENT FOR BASILAR ARTERY ANEURYSM, THE ORBIT COIL (DETAILS UNK) WAS UNRAVELED IN THE PATIENT. TO ATTACH THE COIL AGAINST THE VESSEL, PALMAZ GENESIS (SDS RX GEN AMIIA 5.0X15 142CM, COMPLAINT PRODUCT) WAS USED FOR AN EMERGENCY USE, HOWEVER DURING DELIVERY, LARGE (F/R) FRICTION/RESISTANCE OCCURRED WITH 0.014 TRANSEND EX GUIDEWIRE (GW) PRIOR TO INSERTING IN THE PATIENT. ALTHOUGH THE LARGE F/R WAS STILL EXPERIENCED, THE DEVICE WAS REMOVED FROM THE GW. WHEN THE GW WAS ALSO REMOVED, A PIECE OF FRAGMENT WAS FOUND. THE DISTAL TIP OF THE DEVICE WAS INSPECTED BUT NO DAMAGE WAS FOUND, AND THE PHYSICIAN THOUGHT IT WAS A PART OF THE GW. THE GW WAS CHANGED TO ASAHI CHIKAI GW (ASAHI INTECC). THE DEVICE WAS DELIVERED ONCE AGAIN AND THE STENT WAS PLACED IN THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. AFTER THE PROCEDURE, WHEN THE TRANSEND EX GW AND THE PALMAZ GENESIS WERE INSPECTED ONCE AGAIN, IT SEEMED TO BE THE FRAGMENT COULD BE THE DISTAL TIP OF THE PG DEVICE. THE COMPLAINT PRODUCT WILL BE RETURNED TO YOUR SIDE FOR ANALYSIS TOGETHER WITH THE ASAHI CHIKAI GW. THE TRANSEND EX GW WILL NOT BE RETURNED AS IT WAS ALREADY DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15217435

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention