BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADE

    MDR report key: 12531367 · Received September 27, 2021

    Report

    Report Number
    3003775186-2021-03513
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD.
    Product Code
    LIT
    PMA / PMN Number
    K202231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A JADE OTW ANGIOPLASTY BALLOON WAS USED DURING INTERVENTION ON THE RIGHT RENAL ARTERY VIA LEFT RADIAL APPROACH. AN AORTOGRAM DEMONSTRATED AN OCCLUDED RIGHT RENAL STENT AND CALCIFICATIONS TO THE LEFT RENAL ARTERY WITH NO EVIDENCE OF RENAL ARTERY OR PARENCHYMAL FLOW. INTERVENTION WAS PERFORMED ON THE LEFT RENAL ARTERY, AND A VESSEL INJURY THERE WAS IDENTIFIED AND TREATED WITH A STENT. THE PHYSICIAN THEN CANNULATED THE RIGHT ILIAC AND CHOSE TO ONLY PERFORM ANGIOPLASTY IN THAT AREA IN ORDER TO BE MINIMALLY INVASIVE FOLLOWING THE PRIOR VESSEL INJURY. THE JADE BALLOON WAS INFLATED IN THE COMMON AND EXTERNAL ILIAC ARTERIES SEQUENTIALLY. INFLATION WAS PERFORMED AS PLANNED IN THE EXTERNAL ILIAC ARTERY. THEREAFTER, THE BALLOON BURST AT NOMINAL PRESSURE (18ATM) IN THE COMMON ILIAC. THE BALLOON WAS REMOVED. HOWEVER, THE DISTAL END OF THE BALLOON WAS CAPTURED WITHIN THE STENT. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DISTAL FRAGMENT. COMPLETION OF ANGIOGRAM DEMONSTRATED FLOW DOWN THE RIGHT COMMON ILIAC ARTERY. THE PATIENT HAD SEVERE BACK PAIN AT THE END OF THE OPERATION. THE PATIENT WAS TRANSFERRED INTO RECOVERY IN STABLE CONDITION BUT CONTINUED TO EXPERIENCE BACK PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A THROMBOSIS UNRELATED TO THE REPORTED ISSUE WITH THE BALLOON. THE PATIENT WAS STABLE. THE BALLOON HAD BEEN INADVERTENTLY STORED IN A HOT ENVIRONMENT (90-99F) PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435440 JADE JADE OTW LIT ORBUSNEICH MEDICAL (SHENZHEN) CO. LTD. 5909972104

    Patients

    Seq Age Sex Outcome Treatment
    1