BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿

    MDR report key: 2991432 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01623
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    November 9, 2012
    Report Date
    February 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED AN UNIDENTIFIABLE CATHETER WAS RETURNED; IT HAD BEEN CUT IN TWO PIECES AND BLOOD WAS PRESENT IN THE HUB. THE COIL HAD BEEN CUT WITH THE CATHETER - THE ZAP TIP WAS IN ONE PORTION AND THE REST OF THE COIL WAS PROTRUDING FROM THE OTHER PORTION. THE COIL WAS STRETCHED. A MANDREL WAS INSERTED INTO THE CATHETER TO REMOVE THE COIL, BUT AS RESISTANCE WAS NOTED THE CATHETER WAS CUT DURING ANALYSIS TO REMOVE THE COIL. THE COIL WAS INADVERTENTLY STRETCHED FURTHER AND KINKED DURING REMOVAL FROM THE CATHETER. THE INTERLOCKING ARM OF THE MAIN COIL WAS SLIGHTLY BENT. THERE WAS NO BLOOD ON THE FIBER BUNDLES OF THE COIL. MICROSCOPIC INSPECTION REVEALED THE ZAP TIP SHAPE AND SURFACE WERE SMOOTH. THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. TWO FIBER BUNDLES WERE NOTED TO BE MISSING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DFU STATES: THE INTERLOCK FIBERED IDC OCCLUSION COIL IS DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY WITH A 0.021 IN (0.53 MM) INNER DIAMETER (I.D.) MICROCATHETER (E.G. RENEGADE MICROCATHER WITH ONE OR TWO RADIOPAQUE (RO TIP MARKERS.) IN ORDER TO ACHIEVE EXCELLENT PERFORMANCE OF THE INTERLOCK FIBERED IDC OCCLUSION SYSTEM AND REDUCE THE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT A CONTINUOUS FLOW OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN A) THE MICROCATHETER AND GUIDING CATHETER, AND B) THE MICROCATHETER AND ANY INTRALUMINAL DEVICE. CONTINUOUS FLUSHING: REDUCES RETROGRADE BLOOD FLOW INTO THE MICROCATHETER AND INTRODUCER SHEATH DURING COIL DELIVERY. REDUCES CONTRAST CRYSTAL FORMATION AND/OR THROMBOSIS ON THE DELIVERY WIRE AND IN THE GUIDING CATHETER AND MICROCATHETER LUMENS. REDUCES PREMATURE COIL THROMBOSIS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL BECAME STUCK IN THE MICROCATHETER AND UNRAVELED DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY. UTILIZING INTERMITTENT FLUSH, A NON BSC MICROCATHETER WAS PLACED IN THE VESSEL. THE 4.0MM X 8.0CM INTERLOCK COIL WAS THEN ADVANCED, BUT BECAME STUCK IN THE CATHETER. WHILE RETRACTING THE DEVICE, THE COIL "UNRAVELED." THE DEVICES WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES ON THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95655 INTERLOCK¿ DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361520 15168580

    Patients

    Seq Age Sex Outcome Treatment
    1