BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH RAPIDTRANSIT 135CM W/EXT

    MDR report key: 2880564 · Received December 19, 2012

    Report

    Report Number
    1058196-2012-00454
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 1

    WITH THE REVIEW OF THE INFORMATION PROVIDED THAT ALTHOUGH THERE WAS LOSS OF TARGET SITE, SINCE IT WAS TREATMENT OF A HEPATOCELLULAR CARCINOMA AND NOT AN INTRACEREBRAL VESSEL THE POTENTIAL FOR INJURY ASSOCIATED WITH THE REPORTED EVENT IS REMOTE; THEREFORE, THIS DOES NOT MEET THE REQUIREMENTS FOR A REPORTABLE EVENT. ADDITIONALLY, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) FOR HEPATOCELLULAR CARCINOMA THAT WAS NOT CALCIFIED AND MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A TRANSIT 2 ((B)(4), COMPLAINT PRODUCT) IN AN UNSPECIFIED ANGIOGRAPHY CATHETER (SELECON/TERUMO), THE ANGIOGRAPHY CATHETER LOST TARGET LESION. IT OCCURRED AROUND THE MIDDLE OF THE ANGIOGRAPHY CATHETER. ALTHOUGH THE PHYSICIAN WANTED TO REPOSITION THE ANGIOGRAPHY CATHETER, THERE WAS SEVERE RESISTANCE BETWEEN THE BOTH CATHETERS. THEN, HE FIRSTLY RETRIEVED BOTH THE ANGIOGRAPHY CATHETER AND THE TRANSIT AS A UNIT FROM THE PATIENT AND REPLACED THE ANGIOGRAPHY CATHETER FOR A NEW ONE (DETAIL UNKNOWN). THE PROCEDURE WAS CONTINUED USING THE SAME TRANSIT, BUT THE SITUATION DID NOT IMPROVE. AFTER THAT, THE TRANSIT WAS ALSO REPLACED FOR A NEW ONE ((B)(4)) AND THE PROCEDURE WAS CONTINUED USING THE REPLACED ANGIOGRAPHY CATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THE COMPLAINT PRODUCT WAS SAFELY REMOVED FROM THE PATIENT AND NO PATIENT INJURY/COMPLICATIONS REPORTED. IT IS UNKNOWN HOW MANY COILS WERE PLACED IN THE TARGET LESION DURING THE PROCEDURE. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO, NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH RAPIDTRANSIT 135CM W/EXT CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15459636

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER (SELECON/TERUMO)