BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO

    MDR report key: 6084415 · Received November 7, 2016

    Report

    Report Number
    2029214-2016-00984
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 10, 2016
    Report Date
    December 20, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004/S006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER IT HAS NOT YET BEEN RECEIVED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONALLY, THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. ONCE COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION THE APOLLO MICRO CATHETER WAS RETURNED WITHOUT THE GUIDEWIRE. THEREFORE, ANY CONTRIBUTING FACTORS FROM THE GUIDEWIRE (OTHER THAN THE OUTER DIAMETER SPECIFICATION) COULD NOT BE ASSESSED. THE USABLE LENGTH OF THE MICRO CATHETER WAS WITHIN SPECIFICATION. THE DISTAL FLOPPY LENGTH OF THE MICRO CATHETER WAS ALSO WITHIN SPECIFICATION. NO ISSUES WERE FOUND WITH THE MICRO CATHETER HUB. THE MICRO CATHETER WAS FOUND TO BE PUNCTURED AT ~4.6CM FROM THE DISTAL TIP. THE DETACHABLE TIP WAS FOUND TO BE STILL ATTACHED. THE CATHETER WAS FLUSHED AND WATER EXITED FROM THE PUNCTURED LOCATION AND DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. DURING THE INVESTIGATION, IT WAS FOUND THAT THE GUIDEWIRE (NON-MEDTRONIC WIRE) HAS A PROXIMAL OD (OUTER DIAMETER) OF 0.012¿ AND A DISTAL OD OF 0.007¿ WHICH IS INCOMPATIBLE FOR USE WITH THE APOLLO MICRO CATHETER. BASED ON THE DEVICE ANALYSIS, REPORTED INFORMATION AND CUSTOMER PROVIDED IMAGES, THE CUSTOMER'S REPORT OF "PUNCTURE" WAS CONFIRMED. THE RETURNED APOLLO MICRO CATHETER WAS FOUND TO BE PUNCTURED. IT IS LIKELY THAT THE USE OF AN INCOMPATIBLE GUIDEWIRE CONTRIBUTED TO THE REPORTED ISSUE. PER THE APOLLO ONYX DELIVERY MICRO CATHETER IFU (INSTRUCTIONS FOR USE): ¿THE APOLLO ONYX DELIVERY MICRO CATHETER IS NOT COMPATIBLE WITH NON-HYDROPHILICALLY COATED GUIDEWIRES OR GUIDEWIRES GREATER THAN 0.010¿ IN DIAMETER. DURING NAVIGATION, CHECK THAT THE DISTAL TIP OF THE CATHETER IS NOT KINKED BEFORE PASSING THE GUIDEWIRE THROUGH IT. KINKING OR PROLAPSING OF THE CATHETER MAY RESULT IN UNINTENDED RUPTURE OF THE CATHETER.¿ THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE; THEREFORE MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE GUIDEWIRE PUNCTURED THE APOLLO CATHETER AND PERFORATED THE VESSEL. DURING CATHETER PLACEMENT IT WAS SEEN THAT THE GUIDEWIRE PASSED THE CATHETER PROXIMAL TO THE CATHETER TIP AND ENTERED A SMALL FEEDER. DUE TO BYPASS/PUNCTURE OF THE APOLLO WITH THE GUIDEWIRE A SMALL FEEDER VESSEL WAS RUPTURED. PATIENT WAS ASYMPTOMATIC. THE CATHETER/TIP AND GUIDEWIRE WAS WITHDRAWN AND THE AVM WAS THEN EMBOLIZED WITH A NEW CATHETER AND ONYX. DYNACT SHOWED SMALL BLEEDING SIGNS, BUT THE PATIENT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733040 APOLLO AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-5097-000 A228695

    Patients

    Seq Age Sex Outcome Treatment
    1 Other