BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT

    MDR report key: 12195118 · Received July 20, 2021

    Report

    Report Number
    9681834-2021-00124
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 20, 2021
    Product Code
    DQO
    PMA / PMN Number
    K033583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE IMPLANTED DATE: DEVICE WAS NOT IMPLANTED EXPLANTED DATE: DEVICE WAS NOT EXPLANTED PMA/510(K): K033913 THIS REPORT HAS BEEN DEEMED REPORTABLE BASED UPON VISUAL INSPECTION OF THE ACTUAL SAMPLE UPON RECEIPT. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO KINK OR SIMILAR ANOMALY WAS FOUND IN THE CATHETER, HOWEVER, TEARS AND PEELING OF THE OUTER LAYER WERE OBSERVED FROM APPROXIMATELY 745 MM TO 780 MM FROM THE DISTAL END OF THE GUIDEWIRE. AFTER PRIMING THE INSIDE OF THE ACTUAL CATHETER AND THE SURFACE OF THE GUIDEWIRE, AN ATTEMPT WAS MADE TO INSERT THE GUIDEWIRE IN THE CATHETER. AS A RESULT, IT WAS FOUND THAT THE ENTIRE LENGTH OF THE GUIDEWIRE COULD BE INSERTED WITHOUT RESISTANCE. FROM THIS, IT WAS INFERRED THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE STICKING OF THE GUIDEWIRE AS REPORTED AND THE TEARS AND PEELING OF THE OUTER LAYER OF THE GUIDEWIRE OBSERVED IN. THE ACTUAL CATHETER WAS INSPECTED UNDER A MAGNIFIER. NO ELONGATION, NO CRUSH, OR NO SIMILAR ANOMALY WAS OBSERVED IN THE APPEARANCE. THE LUMEN OF THE CATHETER WAS INSPECTED UNDER X-RAY FLUOROSCOPY AND NO ANOMALY SUCH AS CLOGGING OF THE LUMEN WAS OBSERVED. THE APPEARANCE OF THE TORN OUTER LAYER AREA OF THE ACTUAL GUIDEWIRE WAS INSPECTED WITH A MAGNIFIER. PEELING OF THE OUTER LAYER WAS OBSERVED NEAR THE TORN SITE. IN ADDITION, THE PEELING OF THE OUTER LAYER OCCURRED IN A STRAIGHT LINE FROM APPROXIMATELY 745 MM TO 780 MM FROM THE DISTAL END. NO ABNORMALITY IN THE SURFACE CONDITION WAS OBSERVED IN OTHER AREAS. THE APPEARANCE OF THE TORN AND PEELED OUTER LAYER AREA OF THE ACTUAL GUIDEWIRE WAS INSPECTED USING AN ELECTRON MICROSCOPE. ABRASIONS WERE OBSERVED NEAR THE PEELING AREA. THEREFORE, IT WAS THOUGHT THAT SOME HARD OBJECT HAD COME INTO CONTACT WITH IT. THE OUTER LAYER OF THE NORMAL PART OF THE ACTUAL GUIDEWIRE WAS SCRAPED OFF INTENTIONALLY, AND ITS APPEARANCE WAS CHECKED WITH A MAGNIFIER. THERE WERE NO ANOMALIES IN APPEARANCE SUCH AS POOR ADHESION OR GAPS BETWEEN THE CORE WIRE AND THE OUTER LAYER. THE OUTER AND INNER DIAMETERS OF THE ACTUAL CATHETER WERE MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. THE OUTER DIAMETER OF THE ACTUAL GUIDEWIRE WAS MEASURED AT A NORMAL PART AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. SLIDING RESISTANCE OF THE ACTUAL GUIDEWIRE WAS MEASURED AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. SIMULATION TEST: A GUIDEWIRE THAT COMES WITH COAXIAL TYPE PROGREAT WAS COMBINED WITH A METAL INSERTER, AND THEN THE GUIDEWIRE WAS MANIPULATED WHILE THE DISTAL END OF THE METAL INSERTER IS COMING INTO CONTACT WITH THE GUIDEWIRE. AS A RESULT, THE OUTER LAYER OF THE GUIDEWIRE WAS TORN AND PEELED, WHOSE CONDITION WAS VERY SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: MAKE SURE THAT THE LOCK ADAPTER IS NOT LOOSE. INJECT HEPARINIZED SALINE SOLUTION INTO THE GUIDE WIRE HUB USING THE ATTACHED 2.5 ML LUER LOCK SYRINGE. IN ORDER TO PRIME THE CATHETER SUFFICIENTLY, SLOWLY INJECT AT LEAST 1 ML OF THE SOLUTION INTO THE CATHETER UNTIL MORE THAN 10 DROPS OF THE SOLUTION APPEAR OUT OF ITS TIP. TO MAINTAIN SURFACE LUBRICITY, IMMERSE THE CATHETER AND THE GUIDE WIRE ASSEMBLY IN A HEPARINIZED SALINE SOLUTION BATH OR PUT IT INTO ITS HOLDER FILLED WITH HEPARINIZED SALINE SOLUTION. PRIME THE CATHETER AND GUIDE WIRE SUFFICIENTLY. MANIPULATION OF AN INSUFFICIENTLY PRIMED CATHETER MAY CAUSE WRINKING, SEPARATION OF THE CATHETER, AND/OR ABRASION OF THE HYDROPHILIC COATING ON THE GUIDE WIRE. DO NOT MANIPULATE AND/OR WITHDRAW THE MICRO CATHETER SYSTEM THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN ABRASION OF THE HYDROPHILIC COATING, DESTRUCTION AND/OR SEPARATION OF THE MICRO CATHETER SYSTEM. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ONE OF THE POSSIBILITIES WAS THAT INSUFFICIENT PRIMING WHEN REMOVING THE GUIDEWIRE FROM THE CATHETER CAUSED THE FRICTIONAL RESISTANCE BETWEEN THE INNER SURFACE OF THE CATHETER AND THE OUTER SURFACE OF THE GUIDEWIRE TO INCREASE, RESULTING IN THE STICKING OF THE GUIDEWIRE INSIDE THE CATHETER. AS FOR THE TEARING AND PEELING OF THE OUTER LAYER OF THE ACTUAL GUIDEWIRE, ONE POSSIBILITY WAS THAT IT WAS CAUSED BY THE ABRASIVE LOAD APPLIED TO THE SURFACE OF THE GUIDEWIRE WHEN A HARD OBJECT SUCH AS A METAL INSERTER TIP CAME INTO CONTACT WITH IT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PROGREAT WAS USED PRE-TREATMENT. THE NURSE SPECIALIST REMOVED FROM RUNNER TO FLUSH. TRIED REMOVING WIRE AND STUCK WITHIN PROGREAT MICROCATHETER. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094618 PROGREAT CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO NA 200423

    Patients

    Seq Age Sex Outcome Treatment
    1