BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLEX HELICAL - 18

    MDR report key: 3053512 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02792
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K911312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE COIL WAS RETURNED OUTSIDE OF THE INTRODUCER. THE COVER OF THE POUCH WAS ANALYSED AND NO ANOMALY WAS NOTED. THE SEAL WAS NOT GATHERED OR PINCHED. HOWEVER, THE BASE OF THE POUCH COVER WAS TORN. THE COIL WAS INSPECTED AND FOUND TO BE SLIGHTLY KINKED AT THE ZAP TIP. MICROSCOPIC INSPECTION REVEALED THE APEX ZAP TIP SHAPE AND THE BASE ZAP TIP SHAPE SURFACE WAS SMOOTH. THE DIMENSIONS OF THE COIL WERE FOUND TO BE IN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR AN UNSPECIFIED PROCEDURE, A STERILIZATION ISSUE OCCURRED. DURING UNPACKING OF A 4MM/4MM COMPLEX HELICAL - 18 COIL, IT WAS NOTED THAT THE PRODUCT WAS PACKAGED IN A WAY THAT THE COIL WAS PINCHED IN THE STERILE SEAL OF THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR AN UNSPECIFIED PROCEDURE, A STERILIZATION ISSUE OCCURRED. DURING UNPACKING OF A 4MM/4MM COMPLEX HELICAL - 18 COIL, IT WAS NOTED THAT THE PRODUCT WAS PACKAGED IN A WAY THAT THE COIL WAS PINCHED IN THE STERILE SEAL OF THE PACKAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154791 COMPLEX HELICAL - 18 DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0013120221 0014996074

    Patients

    Seq Age Sex Outcome Treatment
    1