BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP OTW

    MDR report key: 3132484 · Received May 29, 2013

    Report

    Report Number
    3004066202-2013-00084
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULT: (DEVICE EVALUATION NOT YET COMPLETE). EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT (DEVICE EVALUATION IN PROGRESS). INCONCLUSIVE- INVESTIGATION IN PROGRESS (DEVICE EVALUATION NOT YET COMPLETE).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: COMPONENT/SUBASSEMBLY FAILURE-FAILURE WAS RELATED TO CONNECTION BETWEEN INFLATION LINE AND GUIDE WIRE LUMEN. EVALUATION CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO THE EVENT-FAILURE WAS RELATED TO CONNECTION BETWEEN INFLATION LINE AND GUIDE WIRE LUMEN. (B)(4).

    Description of Event or Problem · 1

    EVALUATION SUMMARY: TRACES OF LIQUID WERE DETECTED INSIDE THE BALLOON AND THE SHAFT. THE BALLOON WAS UNFOLDED AND THE GUIDE WIRE LUMEN WAS STRESSED AND BENT. A KINK WAS DETECTED ABOUT 5 CM FROM THE BALLOON. AN ATTEMPT TO INFLATE THE BALLOON WAS PERFORMED BUT A LEAKAGE WAS DETECTED DUE TO LIQUID THAT GOT OUT FROM THE TIP AND FROM THE HUB AT THE GUIDE WIRE LUMEN PORT. IN ORDER TO PERFORM THE ANALYSIS THE HUB WAS CRACKED. A STYLET WAS INSERTED IN TO THE TIP TO CLOSE THE GUIDE WIRE LUMEN DISTALLY AND A SYRINGE FILLED BY RED WATER WAS CONNECTED BY A NEEDLE TO THE GUIDE WIRE TUBE. THE GUIDE WIRE LUMEN WAS PRESSURIZED AND THE RED LIQUID CAME OUT FROM THE INFLATION LINE, CROSSING THE WELDING BETWEEN GUIDE WIRE LUMEN AND INFLATION LINE. THE BALLOON WAS INFLATED FOR FEW MINUTES DUE TO THE LEAKAGE BUT NO PINHOLE WAS DETECTED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A FOCAL LESION IN THE POSTERIOR TIBIAL ARTERY WHICH EXHIBITED 70 % STENOSIS, MINIMAL TORTUOSITY. THE LESION HAD NOT BEEN PRE-DILATED. THE DEVICE WAS INSPECTED AND PREPPED PRIOR TO USE WITH NO ISSUES NOTED. THERE WAS NO EVIDENCE OF AIR IN THE INFLATION LUMEN OR BALLOON OF THE DEVICE. NO FRICTION NOTED WITH THE GW/ GC. HOWEVER IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON TO 12 ATMS, THE BALLOON WOULD NOT INFLATE. THE PRESSURE GAUGE HELD PRESSURE FOR APPROX 1 MIN WHEN IT WAS DETERMINED THAT THE BALLOON WAS NOT INFLATING. THE PHYSICIAN COMMENTED THAT THE BALLOON WAS HOLED. NO PATIENT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234151 AMPHIRION DEEP OTW CATHETER, PERCUTANEOUS DQY INVATEC SPA 1C030822

    Patients

    Seq Age Sex Outcome Treatment
    1