BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 3103012 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03036
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL BECAME STUCK IN THE CATHETER WHILE PARTIALLY DEPLOYED. THE PATIENT PRESENTED WITH HIGH GRADE SPLENIC LACERATIONS FOLLOWING A TRAUMATIC EVENT. SPLENIC ARTERIOGRAM WAS PERFORMED. A 5FR NON BSC CATHETER WAS ADVANCED INTO THE SPLENIC ARTERY. AN UNSPECIFIED SIZE .035 INTERLOCK COIL WAS ADVANCED. WHEN THE COIL WAS PARTIALLY DEPLOYED, APPROXIMATELY 50%, THE PHYSICIAN DETERMINED IT WAS TOO SMALL AS IT WOULDN'T ADEQUATELY COIL. AS HE WAS RETRACTING THE COIL INTO THE CATHETER, HE FELT A CLICK, INDICATING THE COIL HAD DETACHED WITHIN THE CATHETER. A .035 WIRE WAS ADVANCED THROUGH THE CATHETER, BUT WAS UNABLE TO PUSH THE COIL OUT. A SMALL SYRINGE WAS FILLED WITH SALINE AND A FORCEFUL INJECTION ADVANCED THE COIL INTO THE SPLENIC ARTERY. HOWEVER, A "HAIRLINE EXTENSION" WAS NOTED IN THE DISTAL END OF THE CATHETER WHICH CONNECTED TO THE COIL MASS. A NON BSC PUSHABLE COIL WAS THEN ADVANCED, BUT WAS UNABLE TO BE COMPLETELY DEPLOYED DUE TO THE EXTENSION OF THE INTERLOCK COIL. THE PHYSICIAN WITHDREW THE CATHETER, WITH THE PUSHABLE COIL HALF DEPLOYED AND THE INTERLOCK STILL CONNECTED TO THE CATHETER BY THE NOTED EXTENSION. ONCE OUT OF THE CELIAC ARTERY AND IN THE AORTA, HE NOTED THE EXTENSION HAD DISCONNECTED FROM THE CATHETER TIP. AS THE PUSHABLE COIL WAS STILL PARTIALLY DEPLOYED OUT OF THE CATHETER, SLIGHT SUCTION WAS APPLIED AS HE SLOWLY PULLED THE CATHETER AND COIL DOWN THE AORTA AND TO THE RIGHT GROIN VASCULAR SHEATH. HE THEN ACCESSED THE LEFT GROIN AND AFTER A FEW ATTEMPTS, WAS ABLE TO SNARE THE PUSHABLE COIL. THE PROCEDURE WAS ENDED AS THE PHYSICIAN CONFIRMED FLOW HAD STOPPED IN THE SPLENIC ARTERY WITH THE INTERLOCK COIL. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204401 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK UNK716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention