BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 3073209 · Received April 23, 2013

    Report

    Report Number
    1226348-2013-20074
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING COIL EMBOLISATION OF A DUAL ARTERIOVENOUS FISTULA IN THE SUPERIOR PETROSAL SINUS, THE PHYSICIAN COULD NOT DETACH THE DELTAPLUSH (CPL100153-30/C12776, COMPLAINT PRODUCT) ALTHOUGH PRESSING THE DETACHMENT BUTTON TWICE. THEN, PHYSICIAN SLIGHTLY REPOSITIONED THE MICROCATHETER (EXCELSIOR SL10/STRYKER, TYPE UNKNOWN) IN THE TARGET LESION, HE AGAIN ATTEMPTED THE DETACHMENT APPROXIMATELY 8 TIMES, BUT FAILED. ALTHOUGH THE PHYSICIAN REPLACED THE CONNECTING CABLE (CCB000157-00/C12387, COMPLAINT PRODUCT) FOR A NEW ONE (CCB000157-00, LOT UNKNOWN), THE SITUATION DID NOT IMPROVE. THE DETACHMENT CONTROL BOX (DCB000001-20, LOT UNKNOWN) USED WITH THE PRODUCTS WAS NOT REPLACED AT THAT TIME. THE DELTAPLUSH WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS CONTINUED USING AN UNSPECIFIED COMPETITOR'S PRODUCTS (DETAILS UNKNOWN). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. HOWEVER, ACCORDING TO THE PHYSICIAN, AFTER WITHDRAWAL WHEN THE DELTAPLUSH HAD BEEN REMOVED FROM THE PATIENT, THE HEATING COIL OF THE DELTAPLUSH SEEMED TO BE 'BIGGER' COMPARED WITH OTHER LIKE PRODUCTS. BEFORE THE PROCEDURE, THE COIL WAS CHECKED AND APPEARED TO BE CORRECTLY SHAPED. IT WAS REPORTED THAT AFTER THE COMPLAINT PRODUCT, FIVE MICRUS COILS (DELTAPAQ AND ULTIPAQ) WERE SUCCESSFULLY PLACED IN THE TARGET LESION USING THE SAME DCB, BUT IT IS UNKNOWN WHICH CABLE WAS USED WITH SUBSEQUENT COILS AFTER HAVING DIFFICULTIES WITH INITIAL TWO CABLES. NO ISSUES WERE NOTED WITH THE DCB AND IT WAS NOT REPLACED. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE PLACED DURING THE PROCEDURE. THERE WAS NO REPORTED DIFFICULTY DURING REPOSITIONING. 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 DEFECTS (KINKS, BENDS, ETC) WERE NOTED ON THE PRODUCTS BY VISUAL INSPECTION. IT IS UNKNOWN IF THERE WAS ANY DAMAGE NOTED ON THE COIL DELIVERY SYSTEM AFTER REMOVAL FROM THE PATIENT. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. ACCORDING TO THE PHYSICIAN, PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. ALL CONNECTIONS SEEMED TO FIT PROPERLY. THERE WAS NO RESISTANCE/FRICTION DURING ADVANCEMENT/WITHDRAWAL OF THE COIL SYSTEM THROUGH THE MICROCATHETER AND THERE WAS NO UNINTENDED COIL DETACHMENT OBSERVED BY THE USER. THE COIL DELIVERY SYSTEM AND CONNECTING CABLE WERE RETURNED FOR ANALYSIS. UPON RECEIPT AND AS VIEWED THROUGH THE INTRODUCER SHEATH, THE COIL WAS RETURNED SEPARATED FROM THE DEVICE POSITIONING UNIT (DPU) VIA THE DETACHMENT FIBER. THE COIL'S SOCKET RING WAS FOUND SEVERELY BENT NINETY DEGREES DISTALLY AND TO THE OUTSIDE. THE DPU PASSED ELECTRICAL TESTING. THE DETACHMENT FIBER RECEIVED HEAT AND MELTED. THE RETURNED CONNECTING CABLE (C12387) FROM THE SAME PROCEDURE AND CAPTURED IN (B)(4) PASSED ELECTRICAL AND FUNCTIONALITY TESTING AND DID NOT CONTRIBUTE TO THIS FIELD COMPLAINT. THE MOST LIKELY CONTRIBUTING FACTOR TO THE FAILURE OF THE COIL TO DETACH IN THE ANEURYSM FOLLOWED BY AN UNINTENDED DETACHMENT INSIDE THE INTRODUCER SHEATH MAY HAVE OCCURRED WHEN THE COIL'S SOCKET RING WAS BENT NINETY DEGREES DISTALLY. WHEN THE SOCKET RING WAS BENT IT MOST LIKELY CAUSED THE DETACHMENT FIBER TO STRETCH AND LOSE TENSION. WHEN THE DETACHMENT FIBER LOST TENSION BY STRETCHING AND THEN THE DETACHMENT BUTTON WAS PRESSED, THE EXTENDED MELTING DETACHMENT FIBER MAY HAVE TEMPORARILY CAPTURED OR ADHERED TO THE COIL BEFORE RELEASING IT AS AN UNINTENDED DETACHMENT INSIDE THE INTRODUCER SHEATH. WITHOUT THE RETURN OF THE BLACK DETACHMENT CONTROL BOX (DCB) AND THE SL-10 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS ALSO CONTRIBUTED TO THE COMPLAINT EVENT. CONCERNING THE PHYSICIAN'S OBSERVATION THAT THE RESISTIVE HEATING COIL APPEARED LARGER THAN NORMAL, THE RESISTIVE HEATING COILS WERE FOUND TO HAVE BEEN CORRECTLY FABRICATED AND ARE WITHIN ENGINEERING SPECIFICATIONS. WHEN SALINE AND OTHER LIQUIDS ENTER INSIDE THE OUTER SHEATH, THE RESISTIVE HEATING COILS WILL BE MAGNIFIED AND WILL APPEAR LARGER THAN BEFORE USE, ESPECIALLY WHEN BEING COMPARED TO THE 'DRY UNUSED' DEVICES. IT WAS STATED IN THE EVENT DESCRIPTION THAT THE PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT COMPLETED. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, 'VERIFY THE FUNCTIONALITY OF THE MICRUS MICROCOIL DELIVERY SYSTEM BEFORE PROCEEDING WITH MICROCOIL PLACEMENT. THIS NEEDS TO BE DONE WITH THE MICROCOIL STILL IN THE HOOP. TO VERIFY PROPER DCB AND MICROCOIL FUNCTIONALITY A CONNECTING CABLE AND MICROCOIL MUST BE CONNECTED TO THE DCB UNIT. AFTER VERIFICATION OF THE DCB AND CONNECTING CABLE, TURN OFF POWER TO THE DCB AND DISCONNECT THE CONNECTING CABLE FROM THE MICROCOIL UNTIL THE MICROCOIL IS READY TO BE DETACHED. PLEASE REFER TO THE DETACHMENT CONTROL BOX INSTRUCTIONS FOR USE SECTION, LOCATED NEAR THE END OF THIS DOCUMENT, BEFORE PROCEEDING.' 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. BASED ON THE FOREGOING INVESTIGATION, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. ACCORDING TO THE PHYSICIAN, PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. THE COMPLAINT PRODUCTS ARE GOING TO BE RETURNED FOR EVALUATION AND THE COIL REMAIN ATTACHED TO THE DPU OF THE DELTAPLUSH. ALL CONNECTIONS SEEMED TO FIT PROPERLY. THERE WAS NO RESISTANCE/FRICTION DURING ADVANCEMENT/WITHDRAWAL OF THE COIL SYSTEM THROUGH THE MC. 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 PRODUCT DEVICE IS EXPECTED TO BE RETURNED; THUS ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLISATION FOR DUAL ARTERIOVENOUS FISTULA IN SUPERIOR PETROSAL SINUS, IT WAS NOTED THAT THE PHYSICIAN COULD NOT DETACH THE DELTAPLUSH ((B)(4), COMPLAINT PRODUCT) ALTHOUGH PRESSING THE DETACHMENT BUTTON TWICE. THEN, PHYSICIAN SLIGHTLY REPOSITIONED THE MICROCATHETER(EXCELSIOR SL10/STRYKER, TYPE UNKNOWN) IN THE TARGET LESION AND ATTEMPTED THE DETACHMENT FOR ABOUT 8 TIMES, BUT FAILED. ALTHOUGH THE PHYSICIAN REPLACED THE MICRO CABLE ((B)(4), COMPLAINT PRODUCT) FOR A NEW ONE ((B)(4), LOT UNKNOWN), THE SITUATION DID NOT IMPROVE. THE DETACHMENT CONTROL BOX ((B)(4), LOT UNKNOWN) USED WITH THE PRODUCTS WAS NOT REPLACED AT THAT TIME. THEREFORE THE DELTAPLUSH WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS CONTINUED USING UNSPECIFIED COMPETITOR'S PRODUCTS(DETAILS UNKNOWN). IT HASN'T VERIFIED, BUT ACCORDING TO THE PHYSICIAN, AFTER WITHDRAWAL, WHEN THE DELTAPLUSH WAS OUTSIDE THE PATIENT, THE HEATING COIL OF THE DELTAPLUSH SEEMED TO BE BIGGER COMPARED WITH OTHER SAME PRODUCTS. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. BEFORE THE PROCEDURE, THE COIL WAS CHECKED AND CORRECT SHAPED. IT WAS REPORTED THAT AFTER THE COMPLAINT PRODUCT, FIVE MICURS COILS (DELTAPAQ AND ULTIPAQ WERE SUCCESSFULLY PLACED IN THE TARGET LESION USING THE SAME DCB, BUT IT IS UNKNOWN WHICH CABLE WAS USED WITH SUBSEQUENT COILS AFTER HAVING DIFFICULTIES WITH INITIAL TWO CABLES. NO ISSUES NOTED ON THE DCB AS IT WAS NEVER REPLACED. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE PLACED DURING THE PROCEDURE. THERE WAS NO DIFFICULTY DURING REPOSITIONING. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174989 DELTAPLUSH - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA C12776

    Patients

    Seq Age Sex Outcome Treatment
    1