BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO PROGREAT CATHETER

    MDR report key: 17369289 · Received July 21, 2023

    Report

    Report Number
    9681834-2023-00139
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 1, 2023
    Report Date
    July 21, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3: PATIENT SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. E3: OCCUPATION: OTHERS. G4: 510(K) NO:K033583, K033913. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE WAS CONDUCTED. THE OUTER LAYER AT THE DISTAL END HAD BEEN CUT. MAGNIFYING INSPECTION OF THE DISTAL END OF ACTUAL SAMPLE WAS CONDUCTED. THE OUTER LAYER WAS MISSING FOR APPROXIMATELY 20 MM FROM THE DISTAL END. THE OUTER LAYER IN THE VICINITY OF CUT SECTION HAD A FLARING SHAPE FROM THE HAND SIDE TOWARD THE DISTAL SIDE. PART OF THE CUT OUTER LAYER ADHERED TO THE DISTAL END. ALTHOUGH THE COIL AT THE SECTION WHERE THE INNER LAYER WAS EXPOSED HAD BEEN ELONGATED, NO APPEARANCE ANOMALY WAS FOUND IN THE INNER LAYER ITSELF. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE. IT HAD BEEN CRUSHED AT APPROXIMATELY 100 MM FROM THE DISTAL END. NO ANOMALY SUCH AS A KINK OR BEND WAS FOUND IN OTHER SECTIONS. ELECTRON MICROSCOPIC INSPECTION OF THE DISTAL END OF ACTUAL SAMPLE. THE SURFACE OF OUTER LAYER HAD BEEN ROUGHENED. THE OUTER LAYER HAD BEEN FLARED AND HAD A FLARING SHAPE. THERE WERE AN ABRASION AND A FLARING SHAPE ON IT. AS A CAUSE OF THESE ANOMALIES, IT WAS INFERRED THAT ABRASION FORCE WAS APPLIED WHILE IT MET SOME HARD OBJECT. THE INNER LAYER HAD BEEN CRUSHED AND ABRADED AT THE TOP SURFACE OF DISTAL END. AS A CAUSE OF THESE ANOMALIES, IT WAS INFERRED THAT IT CAME IN CONTACT EXCESSIVELY WITH SOME HARD OBJECT. CONFIRMATION OF THE DIMENSION OF ACTUAL SAMPLE, REVEALED OUTER DIAMETER (IN THE VICINITY OF CUT SECTION): IT MET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT #. NO ANOMALY WAS FOUND. PAST COMPLAINT FILE OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT #. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND. BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE OF THIS CASE, THE FOLLOWING MECHANISM WAS INFERRED. SINCE SOME HARD OBJECT MET THE DISTAL END OF ACTUAL SAMPLE, THE OUTER LAYER WAS ABRADED AND ADHESION TO THE INNER LAYER WAS REDUCED. IN THE STATE OF THE ADHESION BETWEEN THE OUTER LAYER AND THE INNER LAYER WAS REDUCED, THE PUSHING OPERATION OF ACTUAL SAMPLE WAS CONTINUED. AS A RESULT, ABRASION FORCE WAS APPLIED TO THE OUTER LAYER OF THE DISTAL END, AND THE OUTER LAYER OF THE DISTAL END WAS FLARED TOWARD THE HAND SIDE. WHEN THE OUTER LAYER WAS FLARED TOWARD THE HAND SIDE, FRICTIONAL FORCE WAS APPLIED TO THE COIL, AND THE COIL WAS ELONGATED. THE FLARED OUTER LAYER INCREASED THE OUTER DIAMETER OF ACTUAL SAMPLE, AND THE ACTUAL SAMPLE WAS TRAPPED. UNDER THE CIRCUMSTANCES, THE PUSHING OPERATION WAS CONTINUED, LEADING TO THE CUTTING OF THE OUTER LAYER. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: 'IF ANY RESISTANCE IS FELT, DO NOT REMOVE THE CATHETER 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 OF THE FRAGMENTS." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED CATHETER, GUIDEWIRE COULD NOT PASS. THE ANGIO-SUITE AT ETZ TREATED A PATIENT WHICH HAD A SPLENIC HEMORRHAGE. AFTER ARTERIAL ACCESS WAS GAINED A 5 FR CELIAC CATHETER WAS INSERTED INTO THE AORTA. THE CELIAC TRUNK WAS SELECTIVELY CATHETERIZED AND A 2.4 FR COAXIAL PROGREAT MC WAS INSERTED. BEFORE INSERTING, THE MC WAS FLUSHED AND AFTER FLUSHING INSERTED THE MC INTO THE 5 FR CATHETER WITHOUT A PROBLEM. AFTER THIS THE PHYSICIAN SEARCHED FOR THE SITE OF THE HEMORRHAGE. DURING THIS SEARCH THE 5 FR CATHETER WAS REPOSITIONED FOR BETTER STABILITY. DURING MC HANDLING FRICTION WAS FELT ON THE COAXIAL WIRE, AND THE WIRE SEEMS TO BE STUCK INSIDE THE MC. THEREFORE, THE MC AND WIRE WERE TAKEN OUTSIDE THE PATIENT AND INVESTIGATED. OUTSIDE THE PATIENT THE WIRE WAS TAKEN OUT OF THE MC. THIS NEEDED MORE FORCE THAN NORMALLY USED. AFTER THE WIRE WAS TAKEN OUT, DAMAGE WAS NOTICED TO THE TIP OF THE PROGREAT MC, AND THE WIRE WAS FINE. A NEW, 2.4 FR NON-COAXIAL PROGREAT, AND THE WIRE WENT IN WITHOUT FRICTION. SO, THE SAME WIRE WAS USED, TOGETHER WITH THE NEW MC AND THE PATIENT UNDERWENT COILING OF HEMORRHAGE WITHOUT FURTHER PROBLEM. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE FINAL PATIENT IMPACT WAS PATIENT BUT NO HARM. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587118 TERUMO PROGREAT CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TERUMO MEDICAL CORPORATION N/A 230209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown