BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    MDR report key: 6367546 · Received March 1, 2017

    Report

    Report Number
    3002808486-2017-00661
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    June 24, 2015
    Report Date
    June 25, 2015
    Manufacturer
    WILL DAVIDSON LLP
    Product Code
    KRD
    UDI-DI
    00827002200265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION OF RETURNED PRODUCTS SHOWED PART OF THE DELIVERY WIRE (TDS) WAS ELONGATED. STRAIGHTENING MANDRIL WAS KINKED AT THE PROXIMAL END OF THE DELIVERY WIRE AND COULD THEREFORE NOT BE ADVANCED INTO THE TIP OF THE COIL (PDA). NO ISSUES FOUND ON THE COIL, HOWEVER IT WAS COILING OUTSIDE THE LOADING CARTRIDGE, WHICH INDICATES THE STRAIGHTENING MANDRIL WAS NOT ADVANCED TO THE TIP OF THE COIL AND THEREFORE THE MANDRIL MAY HAVE KINKED WHEN TRYING TO ADVANCE IT THROUGH THE COILING COIL. THE COIL WAS CLEAN, NO BLOOD OR MATTER WAS SEEN, AND IT SHOWED NO SIGNS OF HAVING BEEN USED IN THE PROCEDURE. BASED ON INVESTIGATION OF RETURNED PRODUCTS AND BY LOOKING AT THE PHOTOS ATTACHED UNDER COMPLAINT INFO, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE FOR THE EVENT, HOWEVER, THE ENCOUNTERED ISSUES MAY HAVE OCCURED DURING LOADING PROCEDURE PRIOR TO PATIENT CONTACT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE COIL (IMWCE-5-PDA5 / (B)(4)) COULD NOT BE DETACHED FROM THE DELIVERY SYSTEM (TDS-110-PDA / (B)(4)) DURING THE PROCEDURE. THEREFORE, THE DEVICES WERE CHANGED WITH ANOTHER IMWCE-5-PDA5 AND TDS-110-PDA TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152370 FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILL DAVIDSON LLP 00827002200265

    Patients

    Seq Age Sex Outcome Treatment
    1