BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK¿

    MDR report key: 2256986 · Received September 21, 2011

    Report

    Report Number
    2134265-2011-04091
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING TREATMENT OF AN ANEURYSM IN THE MILDLY TORTUOUS COMMON HEPATIC ARTERY. INTERMITTENT FLUSH WAS UTILIZED AND A 130CM RENEGADE STC MICROCATHETER WAS PLACED. APPROXIMATELY 8 FIBERED INTERLOCKING DETACHABLE COILS (F-IDC) WERE IMPLANTED. THE 14MM X 30CM F-IDC 2D WAS THEN SELECTED AND AFTER IT HAD BEEN ADVANCED OUT OF THE DISTAL TIP OF THE RENEGADE, THE PHYSICIAN DETERMINED THE CATHETER NEED TO BE RE-POSITIONED. HE RETRACTED THE F-IDC BACK INTO ITS INTRODUCER SHEATH, RE-POSITIONED THE CATHETER AND AS HE WAS READY TO CONTINUE, HE NOTED UNDER FLUOROSCOPY THAT THE COIL HAD ACTUALLY DETACHED INSIDE THE PATIENT. HE UTILIZED A FATHOM GUIDE WIRE TO GENTLY GUIDE THE COIL TO THE CORRECT LOCATION. THE PROCEDURE CONTINUED AND WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCK¿ DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361640 14520274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (8) FIBERED INTERLOCKING DETACHABLE COILS (F-IDC)| 130CM RENEGADE STC MICROCATHETER