BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT CATHETER

    MDR report key: 8686237 · Received June 11, 2019

    Report

    Report Number
    9681834-2019-00090
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    April 16, 2019
    Report Date
    June 11, 2019
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR THE REPORTED PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K) - K033913. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE CATHETER SHAFT HAD BEEN FRACTURED AT APPROXIMATELY 880MM AND 885MM FROM THE DISTAL END OF THE DEVICE. THE FRACTURED FRAGMENT WAS FOUND TO BE APPROXIMATELY 5MM IN LENGTH. THE TOTAL LENGTH OF THE CATHETER SHAFT WAS CONFIRMED TO BE APPROXIMATELY 1300MM, WHICH WAS EQUIVALENT TO THAT OF THE NORMAL PRODUCT OF THIS PRODUCT CODE. FROM THIS, IT IS MOST LIKELY THAT THERE WAS NO MISSING SECTION OF THE CATHETER SHAFT. MAGNIFYING INSPECTION OF THE FRACTURE ENDS (REFERENCED AS A, B AND C) FOUND THAT THE CATHETER SHAFT HAD BEEN STRETCHED AND CRUSHED BY HAVING BEEN PINCHED FROM BOTH DIRECTIONS. AT ALL THE FRACTURE ENDS, EXPOSURE OF THE STAINLESS-STEEL REINFORCEMENT WAS NOTED WITH THE REINFORCEMENT EXPOSED AT THE FRACTURE ENDS B AND C HAVING BEEN COMPLETELY CUT OFF. THE FRACTURE ENDS A, B, AND C WERE RESPECTIVELY INSPECTED FROM THE LATERAL SIDES UNDER ELECTRON MICROSCOPE. ANY ANOMALY, SUCH AS A SCRATCH, WAS NOT FOUND ON THE SURFACE. AT THE FRACTURE ENDS B AND C, THE LENGTH OF THE IMPRESSION OF THE PEELED STAINLESS-STEEL REINFORCEMENT ON THE SHAFT AND THAT OF THE PEELED STAINLESS-STEEL REINFORCEMENT WERE MEASURED AND CONFIRMED TO BE THE SAME. FROM THIS IT IS MOST LIKELY THAT THERE IS NO FRAGMENT OF THE STAINLESS-STEEL REINFORCEMENT MISSING FROM THE ACTUAL DEVICE. THE OUTSIDE AND INSIDE DIAMETERS WERE MEASURED ON THE UNDAMAGED SEGMENT AND CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. REPRODUCTIVE TESTING WAS PERFORMED, AND THE CATHETER SAMPLE OF THIS PRODUCT CODE WAS INSERTED IN A FACTORY-RETAINED ANGIOGRAPHIC CATHETER WHICH HAD A TWO-WAY STOPCOCK AT THE PROXIMAL END. THE STOPCOCK WAS TURNED. THE CATHETER SAMPLE OF THIS PRODUCT CODE BECAME FRACTURED AT TWO POINTS. MAGNIFYING INSPECTION REVEALED THAT THE SHAFT HAD BEEN CRUSHED BY HAVING BEEN PINCHED IN BOTH DIRECTIONS AT TWO POINTS WITH THE EXPOSURE OF THE STAINLESS-STEEL REINFORCEMENT AT THE FRACTURE ENDS. CRUSHES. THE FRACTURED FRAGMENT WAS FOUND TO BE APPROXIMATELY 6MM IN LENGTH. THE DAMAGE LIKE THAT OBSERVED ON THE ACTUAL DEVICE WAS DUPLICATED. A REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT# COMBINATIONS WAS CONDUCTED WITH NO FINDINGS. IFU STATES: 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. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT THE ACTUAL DEVICE BECAME FRACTURED AS THE RESULT OF HAVING BEEN PINCHED BY THE STOPCOCK ATTACHED TO THE DEVICE USED IN COMBINATION WITH THE ACTUAL DEVICE WHEN THE STOPCOCK WAS TURNED WHILE THE ACTUAL DEVICE WAS PLACED IN THE STOPCOCK. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4). EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A TACE (TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION), AFTER THE PROGREAT WAS DELIVERED TO THE TARGET LESION, DURING AN ANGIOGRAPHY WITH AN INJECTOR, THE CUSTOMER HEARD A STRANGE NOISE. THE ACTUAL SAMPLE WAS WITHDRAWN FOR CHECK AND FOUND TO HAVE BEEN ALMOST FRACTURED. THE ACTUAL SAMPLE, AFTER HAVING BEEN REMOVED FROM THE PATIENT, BECAME COMPLETELY FRACTURED OUTSIDE OF THE PATIENT. NO FRAGMENT WAS LEFT IN THE PATIENT. WITH A NEW PRODUCT OF THE SAME CODE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE WHOLE LENGTH OF THE ACTUAL SAMPLE WAS WITHDRAWN FROM THE BODY WITH NO FRAGMENT LEFT IN THE BODY. THE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482342 PROGREAT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA NA 180910

    Patients

    Seq Age Sex Outcome Treatment
    1