BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 3812607 · Received May 15, 2014

    Report

    Report Number
    1226348-2014-00108
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION COULD BE OBTAINED TO EXPLAIN WHY PREMATURE DETACHMENT WAS REPORTED (BUT ONLY STRETCHING WAS FOUND) AND WHY NO ROTATING HEMOSTASIS VALVE (RHV) WAS ATTACHED TO THE DEVICE. DURING COIL EMBOLIZATION OF THE HEPATIC ARTERY, THE COIL SIZE OF THE PRESIDIO (PC4181034-30/C13105, COMPLAINT PRODUCT) WAS NOT PROPER FOR THE TARGET LESION, SO THE PHYSICIAN WANTED TO RE-SHEATH IT. IT WAS REPORTED THAT THERE WAS SEVERE RESISTANCE WHILE WITHDRAWING THE PRESIDIO FROM THE PROWLER SELECT PLUS (606-S255X/15886422), AND THE COIL UNINTENTIONALLY DETACHED AROUND THE MIDDLE SECTION OF THE MICROCATHETER; HOWEVER, PRODUCT ANALYSIS REVEALED THAT THE COIL WAS STRETCHED AND WAS NOT DETACHED. BOTH THE ENTIRE PRESIDIO AND THE PROWLER SELECT PLUS WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING A NEW COIL (PC4181034-30, LOT UNKNOWN) AND MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. IT WAS REPORTED THAT THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE COIL WAS RETURNED STRETCHED; HOWEVER, THE FULL EXTENT OF THE COILS STRETCHING COULD NOT BE DETERMINED PRIOR TO DISSECTING THE MICROCATHETER AND REMOVING THE COIL FROM ITS BLOOD ENCASED PLUG THAT RAN THE COILS ENTIRE LENGTH. THE END USER MAY HAVE STRETCHED THE ANCHORED COIL DURING THE ATTEMPTED REMOVAL. UPON REMOVAL FROM THE MICROCATHETER THE DEVICE POSITIONING UNIT (DPU) WAS STILL FOUND ATTACHED TO THE COIL VIA THE DETACHMENT FIBER; THEREFORE THE UNINTENDED DETACHMENT OF THE COIL INSIDE THE MICROCATHETER DID NOT OCCUR AS REPORTED, AND A ROOT CAUSE CANNOT BE APPLIED TO THIS FIELD COMPLAINT CONCERNING AN UNINTENDED COIL DETACHMENT. IT IS IMPORTANT TO NOTE THAT NO MANUFACTURING DEFECTS WERE FOUND TO THE PROWLER SELECT MICROCATHETER PRIOR TO AND AFTER ITS DISSECTION; HOWEVER, THE MICROCATHETER HAS BEEN SENT FOR FULL ANALYSIS. IT WAS FOUND THAT THE ROTATING HEMOSTATIC VALVE (RHV) WAS NOT FOUND BETWEEN THE STUCK DPU AND THE MICROCATHETERS HUB. IN THIS CONFIGURATION IT WOULD HAVE BEEN IMPOSSIBLE TO REMOVE THE RHV WITHOUT DESTROYING IT OR LEAVING EVIDENCE OF DAMAGING THE DPU AND THE MICROCATHETER¿S HUB. IT WOULD HAVE BEEN DIFFICULT TO HAVE USED THE MICROCOIL SYSTEM AND THE MICROCATHETER INSIDE THE PATIENT OR TO HAVE HAD A CONSTANT PRESSURIZED FLUSH WITHOUT THE RHV IN PLACE. THE CIRCUMSTANCES CANNOT BE DETERMINED OF HOW OR WHY THE RHV WAS NOT RETURNED ATTACHED TO THE MICROCATHETER¿S HUB. THE COPIOUS AMOUNT OF BLOOD INSIDE THE MICROCATHETER THAT PRODUCED A COMPLETE BLOCKAGE MAY HAVE BEEN DUE TO THE LACK OF A CONSISTENT FLUSH. THE FLUSH COULD NOT BE ADMINISTERED WITHOUT THE MISSING RHV. IF A CONSISTENT FLUSH WAS NOT UTILIZED DURING THE PROCEDURE, THEN FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿TO ACHIEVE OPTIMAL PERFORMANCE OF THE CODMAN MICROCOIL SYSTEM, IT IS IMPORTANT THAT A CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION BE MAINTAINED. FIGURE 2 ILLUSTRATES THE CONNECTIONS NECESSARY FOR THE CODMAN MICROCOIL DELIVERY SYSTEM INCLUDING A TYPICAL CONTINUOUS SALINE FLUSH SET UP WITH PRESSURE BAG FOR THE CATHETER SYSTEMS.¿ IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. SEVERAL SEVERELY COMPRESSED SECTIONS WERE FOUND ON THE DISTAL SECTION OF THE MICROCATHETER. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED TO THE MICROCATHETER CANNOT BE DETERMINED AS ALL MICROCATHETERS ARE INSPECTED PRIOR TO FINAL PACKAGING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED PREMATURE DETACHMENT WAS NOT CONFIRMED SINCE THE COIL WAS FOUND TO BE ATTACHED DURING PRODUCT ANALYSIS. COIL STRETCHING WAS CONFIRMED DURING ANALYSIS. RESISTANCE/FRICTION WAS CONFIRMED, AS THE COIL WAS RETURNED ENCASED IN BLOOD WITHIN THE MICROCATHETER. ALTHOUGH THE ROOT CAUSE OF THE STRETCHING AND RESISTANCE/FRICTION COULD NOT BE CONCLUSIVELY DETERMINED, PROCEDURAL/HANDLING FACTORS THAT ARE ADDRESSED IN THE IFU MAY HAVE CONTRIBUTED TO THE COMPLAINT. ALTHOUGH IT WAS REPORTED THAT A CONTINUOUS FLUSH HAD BEEN MAINTAINED WITHIN THE MICROCATHETER, THE RETURNED COIL WAS RETURNED WITH BLOOD INSIDE THE INNER LUMEN AND THE RHV WAS NOT ATTACHED TO THE DEVICE. IN ORDER TO MAINTAIN A FLUSH AND PREVENT BLOOD FROM ENTERING THE MICROCATHETER, A RHV MUST BE ATTACHED. THERE WERE NO ISSUES FOUND DURING PRODUCT ANALYSIS THAT COULD BE RELATED TO A MANUFACTURING ISSUE, THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS 1 OF 2 MDRS ASSOCIATED WITH THIS COMPLAINT WITH ASSOCIATED MANUFACTURER REPORT NUMBERS OF 1226348-2014-00108 AND 1058196-2014-00163.

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY ANALYSIS REVEALED THE COIL WAS NOT DETACHED, BUT THAT THE COIL WAS ENCASED IN BLOOD INSIDE THE MICROCATHETER. WHEN THE MICROCATHETER WAS OPENED TO ANALYZE THE COIL, THE COIL WAS FOUND TO BE STRETCHED. THE MICROCATHETER HAS BEEN SENT FOR FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS 1 OF 2 MDRS ASSOCIATED WITH THIS COMPLAINT WITH ASSOCIATED MANUFACTURER REPORT NUMBERS OF 1226348-2014-00108 AND 1058196-2014-00163. THE COIL WAS RETURNED STRETCHED; HOWEVER, THE FULL EXTENT OF THE COILS STRETCHING CANNOT BE DETERMINED PRIOR TO DISSECTING THE MICROCATHETER AND REMOVING THE COIL FROM ITS BLOOD ENCASED PLUG THAT RAN THE COILS ENTIRE LENGTH. THE END USER MAY HAVE STRETCHED THE ANCHORED COIL DURING THE ATTEMPTED REMOVAL. UPON REMOVAL FROM THE MICROCATHETER, THE DEVICE POSITIONING UNIT (DPU) WAS STILL FOUND ATTACHED TO THE COIL VIA THE DETACHMENT FIBER; THEREFORE THE UNINTENDED DETACHMENT OF THE COIL INSIDE THE MICROCATHETER DID NOT OCCUR AS REPORTED, AND A ROOT CAUSE CANNOT BE APPLIED TO THIS FIELD COMPLAINT CONCERNING AN UNINTENDED COIL DETACHMENT. IT IS IMPORTANT TO NOTE THAT NO MANUFACTURING DEFECTS WERE FOUND TO THE PROWLER SELECT MICROCATHETER PRIOR TO AND AFTER ITS DISSECTION; HOWEVER, THE MICROCATHETER HAS BEEN SENT FOR FULL ANALYSIS. IT WAS FOUND THAT THE ROTATING HEMOSTATIC VALVE (RHV) WAS NOT FOUND BETWEEN THE STUCK DPU AND THE MICROCATHETERS HUB. IN THIS CONFIGURATION IT WOULD HAVE BEEN IMPOSSIBLE TO REMOVE THE RHV WITHOUT DESTROYING IT OR LEAVING EVIDENCE OF DAMAGING THE DPU AND THE MICROCATHETER'S HUB. IT WOULD HAVE BEEN DIFFICULT TO HAVE USED THE MICROCOIL SYSTEM AND THE MICROCATHETER INSIDE THE PATIENT OR TO HAVE HAD A CONSTANT PRESSURIZED FLUSH WITHOUT THE RHV IN PLACE. THE CIRCUMSTANCES CANNOT BE DETERMINED OF HOW OR WHY THE RHV WAS NOT RETURNED ATTACHED TO THE MICROCATHETER'S HUB. THE COPIOUS AMOUNT OF BLOOD INSIDE THE MICROCATHETER THAT PRODUCED A COMPLETE BLOCKAGE MAY HAVE BEEN DUE TO THE LACK OF A CONSISTENT FLUSH. THE FLUSH COULD NOT BE ADMINISTERED WITHOUT THE MISSING RHV. IF A CONSISTENT FLUSH WAS NOT UTILIZED DURING THE PROCEDURE, THEN FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, "TO ACHIEVE OPTIMAL PERFORMANCE OF THE CODMAN MICROCOIL SYSTEM, IT IS IMPORTANT THAT A CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION BE MAINTAINED. FIGURE 2 ILLUSTRATES THE CONNECTIONS NECESSARY FOR THE CODMAN MICROCOIL DELIVERY SYSTEM INCLUDING A TYPICAL CONTINUOUS SALINE FLUSH SET UP WITH PRESSURE BAG FOR THE CATHETER SYSTEMS." IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. SEVERAL SEVERELY COMPRESSED SECTIONS WERE FOUND ON THE DISTAL SECTION OF THE MICROCATHETER. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED TO THE MICROCATHETER CANNOT BE DETERMINED AS ALL MICROCATHETERS ARE INSPECTED PRIOR TO FINAL PACKAGING. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(6). INFORMATION ABOUT PATIENT AGE, GENDER, WEIGHT OR CONCOMITANT MEDICATIONS WAS NOT PROVIDED. THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF THE HEPATIC ARTERY, THE COIL SIZE OF THE PRESIDIO (PC4181034-30/C13105, COMPLAINT PRODUCT) WAS NOT PROPER FOR THE TARGET LESION, SO THE PHYSICIAN WANTED TO RE-SHEATH IT. HOWEVER, WHILE WITHDRAWING THE PRESIDIO FROM THE PATIENT, THERE WAS SEVERE RESISTANCE INTO THE PROWLER SELECT PLUS (606-S255X/15886422, COMPLAINT PRODUCT). SHORTLY AFTER, THE COIL UNINTENTIONALLY DETACHED AROUND THE MIDDLE SECTION OF THE MICROCATHETER ALTHOUGH NO DETACHMENT WAS ATTEMPTED AT THAT TIME. THEREFORE BOTH THE ENTIRE PRESIDIO AND THE PROWLER SELECT PLUS WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING A NEW COIL (PC4181034-30, LOT UNKNOWN). IT IS UNKNOWN IF THE MICROCATHETER WAS REPLACED OR NOT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291816 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C13105

    Patients

    Seq Age Sex Outcome Treatment
    1