BEUDAMED
    FDA Recall Open, Classified

    SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

    Recall: Z-1002-2022 · Initiated February 24, 2022

    Recall

    Recall Number
    Z-1002-2022
    Event Number
    89862
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    OVB
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    February 24, 2022
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

    Reason

    Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

    Action

    An URGENT MEDICAL DEVICE PRODUCT ADVISORY dated 2/24/22 was sent to customers. Inadvertent placement of SpaceOAR gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis, led to embolism. Boston Scientific will incorporate best practices regarding hydrogel placement during all SpaceOAR procedures into the IFU. The updated IFUs will be packaged with SpaceOAR and SpaceOAR Vue Systems after regulatory approvals are obtained for the IFU updates. This Product Advisory contains the recommended IFU updates, located in Appendix 1, intended to: -Raise awareness of embolism as an existing adverse event. -Add new Warnings and Precautions that describe technique recommendations for the placement of SpaceOAR and SpaceOAR Vue to reduce the unintentional placement of hydrogel. - Add procedural instructions to reduce the unintentional placement of hydrogel in a blood vessel and steps to verify placement of the hydrogel following implantation. NO product is being recalled and you are NOT required to return product to Boston Scientific. As per the IFU, SpaceOAR and SpaceOAR Vue System procedures should only be performed by physicians who have received appropriate training for proper hydrogel spacer deployment technique. The Acknowledgement Form must be completed and returned even if you do not have any affected units. Return the Acknowledgement Form by Email: [email protected] or Fax to: Field Action Center 1-763-415-7708

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    61,852 units