BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT CATHETER

    MDR report key: 3962688 · Received July 29, 2014

    Report

    Report Number
    9681834-2014-00210
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 29, 2014
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SECTION WAS COMPLETED BY THE MANUFACTURER PER CFR 803.52(F)(11) BECAUSE THE INFORMATION WAS NOT INITIALLY COMPLETED BY THE USER FACILITY. THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. VISUAL INSPECTION CONFIRMED THAT THE ACTUAL SAMPLE HAD BEEN FRACTURED AT APPROXIMATELY 265MM FROM THE DISTAL END OF THE STRAIN RELIEF. MAGNIFYING INSPECTION OF THE FRACTURE CROSS-SECTION FOUND THAT THE PATENCY OF THE LUMEN WAS STILL INTACT BUT THE TUBE HAD BEEN DEFORMED INTO AN OVAL SHAPE. THIS SUGGESTS THAT THE TUBE WAS PINCHED WITH AN OBJECT. ELECTRON MICROSCOPIC INSPECTION OF THE SEGMENT AROUND THE FRACTURE CROSS-SECTION DID NOT REVEAL THE PRESENCE OF ANY FLAWS OR SCRATCHES THAT COULD HAVE CAUSED A GENERATION OF A FRACTURE. FURTHER INSPECTION CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES AND PRODUCT PERFORMANCE SPECIFICATIONS WERE MET. THREE (3) VARYING REPRODUCTIVE TESTS WERE CONDUCTED USING THE CURRENT CATHETER, A GUIDEWIRE SAMPLE AND A PARENT CATHETER. THE ACTUAL SAMPLE'S DAMAGE COULD NOT BE DUPLICATED, AND THE ACTUAL CAUSE OF THE EVENT COULD NOT BE DEFINITIVELY DETERMINED. HOWEVER, THE RESULTS OF THE REPRODUCTIVE TESTS INDICATE THE ACTUAL SAMPLE WAS PINCHED BY A HARD OBJECT CAUSING THE FRACTURE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO PRODUCT OR MANUFACTURING RELATED ANOMALIES. A SEARCH OF THE COMPLAINT FILE DID NOT FIND ANY OTHER REPORT WITH THE INVOLVED PRODUCT CODE AND LOT NUMBER. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE BY STATEMENTS INCLUDING, "WARNING: IF THE GUIDING CATHETER IS FITTED WITH A STOPCOCK, DO NOT CLOSE THE STOPCOCK WITH THE MICRO CATHETER SYSTEM INSIDE THE GUIDING CATHETER. THE MICRO CATHETER SYSTEM MAY BE BROKEN." ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN PLACED ON FILE BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE TO PLACE A RESERVOIR, THE PROGREAT CATHETER WAS USED CONCOMITANTLY WITH A HANAKO SHEPHERD HOOK WHICH RESULTED IN NO TORQUE FORCE BEING TRANSMITTED TO THE PROGREAT CATHETER. THE ATTENDING PHYSICIAN WITHDREW THE ENTIRE SYSTEM, INCLUDING THE PROGREAT CATHETER, AFTER CLAMPING THE DISTAL END OF THE HANAKO SHEPHERD HOOK. IT WAS DISCOVERED THAT THE PROGREAT CATHETER HAD BECOME FRACTURED IN THE PARENT CATHETER AT APPROXIMATELY 265MM FROM THE DISTAL END OF THE STRAIN RELIEF (APPROXIMATELY 835MM FROM THE DISTAL END OF THE DEVICE). THE ATTENDING PHYSICIAN CONFIRMED THAT NO PORTION OF THE ACTUAL DEVICE REMAINED IN THE PATIENT AND CUT THE ACTUAL SAMPLE AT APPROXIMATELY 440MM - 835MM FROM THE DISTAL END AND DISCARDED IT. REPORTEDLY, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440844 PROGREAT CATHETER CORONARY GUIDING CATHETER DQO TERUMO CORPORATION, ASHITAKA NA 140108

    Patients

    Seq Age Sex Outcome Treatment
    1 HANAKO SHEPHERD HOOK