BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

    MDR report key: 14623173 · Received June 7, 2022

    Report

    Report Number
    3016257349-2022-00001
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    May 9, 2022
    Report Date
    August 3, 2023
    Manufacturer
    PHILIPS IMAGE GUIDED THERAPY CORPORATION
    Product Code
    ONU
    UDI-DI
    00813132028992
    PMA / PMN Number
    P160049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT''S DOB IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. PATIENT INFORMATION REGARDING MEDICAL HISTORY IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. THE STELLAREX DEVICE WAS INFECTIOUS AND DISCARDED BY THE FACILITY, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    BLOCKS D1/ G1: MANUFACTURER NAME AND ADDRESS WAS UPDATED FROM THE SPECTRANETICS CORPORATION, 5905 NATHAN LN N, PLYMOUTH, MN 55442 TO PHILIPS IMAGE GUIDED THERAPY CORPORATION, 9965 FEDERAL DRIVE, COLORADO SPRINGS, CO 80921 TO MATCH THE INFORMATION ON THE PRODUCT LABEL.

    Additional Manufacturer Narrative · 0

    BLOCKS D1/ G1: MANUFACTURER ADDRESS WAS UPDATED FROM 9965 FEDERAL DRIVE, COLORADO SPRINGS, CO 80921 TO 5905 NATHAN LANE NORTH, PLYMOUTH, MN 55442. THIS CORRECTION WAS MADE TO ALIGN THE ADDRESS WITH THE FDA REGISTRATION NUMBER.

    Description of Event or Problem · 0

    THE STELLAREX DEVICE WAS DELIVERED TO THE SLIGHTLY CALCIFIED PROXIMAL SFA WITH NO RESISTANCE. THE BALLOON WAS PRESSURIZED TO 8 ATM, BUT DID NOT APPEAR TO INFLATE COMPLETELY. AFTER INFLATION, THE BALLOON WOULD NOT DEFLATE AND HAD TO STICK A NEEDLE IN THE SFA, RESULTING IN APPROXIMATELY A 15 MINUTE DELAY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE BALLOON UNABLE TO DEFLATE REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075185 STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON DCB PTA CATHETER ONU PHILIPS IMAGE GUIDED THERAPY CORPORATION AB35SX060120135 P3422A14A 00813132028992

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention PHILIPS: 0.014" PHOENIX LIGHT SUPPORT GUIDEWIRE.| TERUMO GUIDE CATHETER SIZE UNK.| TERUMO: 7F DESTINATION INTRODUCER SHEATH.