BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 INDEFLATOR INFLATION DEVICE

    MDR report key: 6170153 · Received December 13, 2016

    Report

    Report Number
    2024168-2016-08818
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 13, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    UDI-DI
    08717648013591
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: DILATATION CATHETER: SAPPHIRE II, NC TRAVELER, GUIDE WIRE: BMW UNIVERSAL II, GUIDE CATHETER: HYPERION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE OTHER INDEFLATOR 20/30 REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, ECCENTRIC, DE NOVO DISTAL RIGHT CORONARY ARTERY THAT WAS 99% STENOSED. PRE-DILATATION WAS BEING PERFORMED WITH A 2.0 NON-ABBOTT BALLOON CATHETER AND A 20/30 INDEFLATOR WHEN THE NEEDLE ON THE GAUGE WOULD NOT MOVE. A NEW INDEFLATOR WAS USED BUT THE NEEDLE ON THE GAUGE ALSO WOULD NOT MOVE. PRE-DILATATION WAS SUCCESSFULLY PERFORMED WITH ANOTHER INDEFLATOR AND A XIENCE ALPINE STENT WAS DEPLOYED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820025 20/30 INDEFLATOR INFLATION DEVICE ACCESSORY KIT MAV AV-TEMECULA-CT 50961912 08717648013591

    Patients

    Seq Age Sex Outcome Treatment
    1