BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAMAXX - PLATINUM MICROCOIL

    MDR report key: 5996583 · Received October 4, 2016

    Report

    Report Number
    2954740-2016-00225
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 12, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    10878528001727
    PMA / PMN Number
    K120274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A LARGE AVM FISTULA EMBOLIZATION OR AN UNSPECIFIED VESSEL, THE DELTAMAXX COIL (DMX18073320/ P11615) DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE DEVICE. THERE WERE 11 CODMAN COILS DEPLOYED BEFORE THE COIL AND 37 COILS WERE DEPLOYED AFTER THE COIL. ONLY TWO MICROCATHETERS AND 2 CONTROL CABLES WERE USED DURING THE PROCEDURE AND ALL OTHER COILS WERE DEPLOYED NORMALLY. THERE WAS NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER, AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE MICROCATHETER DID NOT APPEAR DAMAGED, AND THE COIL WAS REMOVED FROM THE MICROCATHETER, WITHOUT PREMATURE DETACHMENT. THE SAME ENPOWER CABLE AND DETACHMENT CONTROL DEVICE WERE USED TO DETACH SUBSEQUENT COILS. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. LOW BATTERY LIGHT OR FAULT LIGHT HAD NOT BEEN SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. INFORMATION REGARDING PATIENT AGE, GENDER AND MEDICAL HISTORY COULD NOT BE OBTAINED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. THE DELTAMAXX WAS RETURNED FOR ANALYSIS. THE UNSPECIFIED ENPOWER DETACHMENT CONTROL BOX (DCB), THE UNKNOWN CONNECTING CABLE, AND THE UNIDENTIFIED MICROCATHETER WERE NOT RETURNED. CONCERNING CLEANLINESS ONLY, THE MICROCOIL SYSTEM WAS RETURNED IN ALMOST PRISTINE CONDITION. THE SYSTEM WAS EITHER NOT USED OR WAS CLEANED BEFORE BEING RETURNED WHICH MAY HAVE PRODUCED FURTHER DAMAGE. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 52.0 OHMS (RANGE 48.5/56.0), AND THE LAB SAMPLE ENPOWER AND CABLE SYSTEMS READY GREEN LIGHT ILLUMINATED. THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE. POST-DETACHMENT INSPECTION FOUND THAT THE ENPOWER SYSTEMS READY GREEN LIGHT REMAINED ILLUMINATED AND THE RESISTANCE PASSED AT 52.1 OHMS. THE FIELD COMPLAINT OF THE COILS NON-DETACHMENT COULD NOT BE DUPLICATED. POST-DETACHMENT INSPECTION FOUND THAT THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. NO MANUFACTURING DEFECTS WERE FOUND. 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 DELTAMAXX COIL NON-DETACHMENT WAS NOT CONFIRMED. THE DPU PASSED ELECTRICAL TESTING AND THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE, THEREFORE THE ROOT CAUSE OF THE COILS NON-DETACHMENT CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE UNIDENTIFIED MICROCATHETER USED IN THE PROCEDURE IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: KRD/HCG. (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A LARGE AVM FISTULA EMBOLIZATION OR AN UNSPECIFIED VESSEL, THE DELTAMAXX COIL (DMX18073320/ P11615) DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE DEVICE. THERE WERE 11 CODMAN COILS DEPLOYED BEFORE THE COIL AND 37 COILS WERE DEPLOYED AFTER THE COIL. ONLY TWO MICROCATHETERS AND 2 CONTROL CABLES WERE USED DURING THE PROCEDURE AND ALL OTHER COILS WERE DEPLOYED NORMALLY. THERE WAS NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER, AND A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE MICROCATHETER DID NOT APPEAR DAMAGED, AND THE COIL WAS REMOVED FROM THE MICROCATHETER, WITHOUT PREMATURE DETACHMENT. THE SAME ENPOWER CABLE AND DETACHMENT CONTROL DEVICE WERE USED TO DETACH SUBSEQUENT COILS. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. LOW BATTERY LIGHT OR FAULT LIGHT HAD NOT BEE SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. INFORMATION REGARDING PATIENT AGE, GENDER AND MEDICAL HISTORY COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647495 DELTAMAXX - PLATINUM MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA P11615 10878528001727

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER DCB AND CABLE (CATALOG/LOT UNK)