BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11720572 · Received April 23, 2021

    Report

    Report Number
    3004742232-2021-00147
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 6, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K190634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THIS PRODUCT WAS PERFORMED BY THE ORIGINAL MANUFACTURER, FRESENIUS KABI. FRESENIUS KABI PROVIDED THE FOLLOWING ANALYSIS CONCLUSION: TEN SAMPLES OF THE LOT NUMBERS 10NL2942 AND 10NI1261 WERE RECEIVED FOR THE EVALUATION OF THIS EVENT. IT WAS UNKNOWN WHICH LOT NUMBER WAS USED DURING THE EVENT. THE SAMPLES WERE UNABLE TO BE INVESTIGATED AS IT WAS UNKNOWN IF UNFULFILLED ENVIRONMENTAL REQUIREMENTS OR CUSTOMER HANDLING MAY HAVE AFFECTED THE PACKAGES. THE CERTIFICATE OF CONFORMITY FOR BOTH LOT NUMBERS INDICATES NO ANOMALIES; ALL TEST RESULTS WERE WITHIN LIMITS AND IN CONFORMANCE WITH VALID SPECIFICATIONS. THE TWO BATCHES ARE MANUFACTURED ACCORDING TO GMP GUIDELINES. THERE WERE NO DEVIATIONS REPORTED DURING PRODUCTION AND QUALITY CONTROL OF THE BATCHES. THESE BATCHES MET ALL SPECIFICATION REQUIREMENTS. LOT NUMBER INFORMATION: 10NL2942: (01)30852528005125(17)211031(10)10NL2942; MANUFACTURE DATE: 11/13/2019; 10NI1261: (01)30852528005125(17)210831(10)10NI1261; MANUFACTURE DATE: 9/26/2019. CSI ID# (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF SAMPLES OF THE SAME LOT OF THE REPORTED DEVICE IS IN PROGRESS BY THE ORIGINAL MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. CSI ID# (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SHAKING, CHILLS, SHORTNESS OF BREATH, FEVER, AGITATION AND NAUSEA APPROXIMATELY 10 MINUTES AFTER ATHERECTOMY TREATMENT. THE OPINION OF THE PHYSICIAN WAS THAT THE SYMPTOMS WERE CAUSED FROM A REACTION TO THE VIPERSLIDE LUBRICANT. ANTIHISTAMINES, STEROIDS, IV FLUIDS, AND OXYGEN WERE ADMINISTERED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611583 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R