BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACIFIC PLUS

    MDR report key: 3970628 · Received July 31, 2014

    Report

    Report Number
    3004066202-2014-00120
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K123358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FAILURE WAS NOT REPLICATED THROUGH THE DEVICE ANALYSIS. EVENT MOST LIKELY PROCEDURAL RELATED (USE OF DEVICE IN A PRE-CLINICAL ANIMAL STUDY). CONCLUSION: FAILURE WAS NOT REPLICATED THROUGH THE DEVICE ANALYSIS. EVENT MOST LIKELY PROCEDURAL RELATED (USE OF DEVICE IN A PRE-CLINICAL ANIMAL STUDY). (B)(4).

    Description of Event or Problem · 1

    A PACIFIC PLUS BALLOON DEVICE WAS BEING USED IN A PRECLINICAL MEDTRONIC ANIMAL STUDY LEFT FEMORAL ARTERIOVENOUS FISTULA SETTING. NO ABNORMALITY NOTED DURING PREPARATION AND INSPECTION OF THE DEVICE PRIOR TO USE. THE LAB INTERVENTIONIST INSERTED THE DEVICE AND ADVANCED TO THE TARGET TREATMENT SITE IN THE PORCINE VASCULATURE WITHOUT DIFFICULTY. THE BALLOON WAS INFLATED TO 12 ATM USING A 50:50 SALINE: CONTRAST MIX. AFTER THE INFLATION PERIOD, THE PRESSURE WAS RELEASED FROM THE INFLATION DEVICE IN ORDER TO DEFLATE THE BALLOON FOR REMOVAL FROM THE ANATOMY. THE BALLOON DEFLATION TIME WAS MUCH LONGER THAN EXPECTED AND REQUIRED ADDITIONAL MEANS TO ACHIEVE. THE INFLATION DEVICE WAS USED, REMOVED, AND THEN REPLACED WITH A 12ML SYRINGE. THE INFLATION DEVICE WAS ATTACHED AGAIN AND ATTEMPTS WERE MADE TO DEFLATE. THE INFLATION DEVICE WAS REMOVED AND REPLACED WITH A 20ML SYRINGE. IT TOOK APPROXIMATELY 13.5 MINUTES FOR THE BALLOON TO FULLY DEFLATE. EVALUATION SUMMARY: A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUE WAS IDENTIFIED. THE GUIDE WIRE LUMEN WAS FULL OF BLOOD; HOWEVER IT WAS POSSIBLE TO CLEAN IT AFTER AN ACCURATE FLUSHING. A 0.018¿¿ GUIDE WIRE WAS INSERTED THROUGH THE ENTIRE LENGTH WITHOUT ANY PROBLEM. TO VERIFY THE DEFLATION TIME, A MANOMETRIC SYRINGE WAS PARTIALLY FILLED WITH 1:1 MIXTURE OF CONTRAST MEDIA AND SALINE SOLUTION. DEVICE WAS INFLATED AT RBP (12 ATM) AND THEN, APPLYING NEGATIVE PRESSURE THE DEFLATION TIME WAS MEASURED WITH THE CHRONOMETER. DEFLATION TIME WAS MEASURED THREE TIMES, WITH ALWAYS THE SAME RESULTS, APPROXIMATELY 27 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446833 PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA 1F010269

    Patients

    Seq Age Sex Outcome Treatment
    1