BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO PROGREAT CATHETER

    MDR report key: 15690262 · Received October 28, 2022

    Report

    Report Number
    9681834-2022-00211
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 28, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WEIGHT: 56. UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K033913. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE PROVIDED CINE IMAGE WAS CONFIRMED, AND THE FOLLOWING RESULTS WERE OBTAINED. THE CATHETER WAS INSERTED THROUGH AN ANGIOGRAPHIC CATHETER. THE CATHETER WAS BROKEN OFF AND ITS RESIDUE REMAINED IN THE PATIENT. ADDITIONAL INFORMATION FROM TMSH INDICATED AS FOLLOWS. THE OBJECT SHOWN IN THE CINE IMAGE WAS THE RESIDUE OF THE ACTUAL CATHETER. BEFORE THE ACTUAL SAMPLE BROKE OFF, PHYSIOLOGICAL SALINE SOLUTION HAD BEEN INJECTED TO IT WITH A NORMAL SYRINGE CONNECTED TO ITS HUB. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NOT ANY ANOMALIES IN THEM. IN ADDITION, NO NON-CONFORMING PRODUCTS DUE TO RUPTURE OR LEAKAGE WERE FOUND IN THE PRESSURE RESISTANCE AND LEAKAGE TESTS. IT WAS MOST UNLIKELY THAT THE STRENGTH OF THE CATHETER WOULD DECREASE, AND THE CATHETER WOULD BE BROKEN OFF ONLY DUE TO THE INJECTION PRESSURE WITH A SYRINGE. IT WAS CONSIDERED POSSIBLE THAT SOME FORCE HAD BEEN APPLIED TO THE INVOLVED SITE OF THE ACTUAL SAMPLE CAUSING IT TO BREAK OFF, AND THEN WHEN THE PHYSIOLOGICAL SALINE SOLUTION WAS INJECTED, THE DISTAL PORTION MIGRATED DISTALLY IN THE VESSEL AND SEPARATED COMPLETELY FROM THE PROXIMAL PORTION. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. FROM THE INVESTIGATION RESULTS, THE FOLLOWING POSSIBILITY WAS INFERRED AS A CAUSE OF OCCURRENCE IN THIS CASE; HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND THE DETAILS OF THE PROCEDURE WERE UNKNOWN, THE CAUSE OF THE OCCURRENCE COULD NOT BE CLARIFIED. THE DISTAL END OF THE ACTUAL SAMPLE WAS TRAPPED BY SOME FACTOR (E.G., LESION SITE). THE ACTUAL SAMPLE IN THE STATE DESCRIBED ABOVE WAS SUBJECTED TO EXCESSIVE FORCE (E.G., TENSILE FORCE), WHICH RESULTED IN THE BREAKAGE AT THE INVOLVED SITE. PHYSIOLOGICAL SALINE SOLUTION WAS INJECTED WITH THE SYRINGE CONNECTED TO THE HUB OF THE ACTUAL SAMPLE. AS A RESULT, THE DISTAL PORTION OF THE ACTUAL SAMPLE MIGRATED DISTALLY IN THE VESSEL AND SEPARATED COMPLETELY FROM THE PROXIMAL PORTION. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "DIRECTIONS FOR USE: WHEN USING MANY EMBOLIC MATERIALS, IT IS RECOMMENDED TO CHANGE THE CATHETER EACH TIME." "WARNING: IF ANY RESISTANCE IS FELT, DO NOT REMOVE THE MICRO CATHETER SYSTEM BY FORCE. WITHDRAW THE CATHETER CAREFULLY TOGETHER WITH THE GUIDING CATHETER. REMOVING THE CATHETER BY FORCE MAY RESULT IN THE CATHETER BREAKAGE/SEPARATION, WHICH MAY NECESSITATE RETRIEVAL." (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN ARTERIAL EMBOLIZATION OF THE LEFT GASTRIC ARTERY (FROM THE LEFT SIDE OF THE LIVER) AND CELIAC TRUNK ARTERIOGRAPHY WAS PERFORMED. WHEN DELIVERING THE THIRD EMBOLIZATION COIL FROM THE PROGREAT INVOLVED, THE PHYSICIAN INJECTED 0.5ML OF LIQUID, RESISTANCE WAS FELT, AND THE MICROCATHETER BROKE AT 7-8CM FROM THE DISTAL END. THE CLINICAL PHYSICIAN CONFIRMED ALL THE EMBOLIZATION COILS RELEASED AT THE TARGET SITE AND THE PROCEDURE WAS COMPLETED. PER CLINICAL ASSESSMENT, A SECOND PROCEDURE TO REMOVE THE PRODUCT RESIDUE WILL NOT BE PLANNED. THE CATHETER HAD BROKEN OFF AND REMAINED IN THE PATIENT'S BODY. PRODUCT RESIDUE WAS LEFT IN THE PATIENT. THE PATIENT WAS HARMED; HOWEVER, NOT SERIOUSLY. ADDITIONAL INFORMATION WAS RECEIVED ON 11 OCT 2022: THE PHYSICIAN INJECTED SALINE BY A NORMAL SYRINGE WHICH WAS CONNECTED TO THE PRODUCT HUB. NO POWER INJECTOR WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON 17 OCT 2022: THE PRODUCT RESIDUE WAS FROM THE CATHETER ITSELF, NOT GUIDEWIRE ANNEXED. IT WAS CONFIRMED THAT THE RESIDUAL PRODUCT IS CURRENTLY IN THE "LEFT GASTRIC ARTERY". THE LEFT GASTRIC ARTERY EMANATES FROM THE LEFT HEPATIC ARTERY, DUE TO THE PATIENT HAVING POSTOPERATIVE GASTRIC CANCER, THE BLOOD SUPPLYING IS RELATIVELY DISORGANIZED AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2764763 TERUMO PROGREAT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO CORPORATION, ASHITAKA N/A 210112

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other