The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a seal biopsy valve was used in an unknown procedure performed on (b)(6) 2019.According to the complainant, during procedure, the seal biopsy valve was leaking out of the side.The procedure was completed using a device from another manufacturer.No patient complications were reported, as a result of this event.
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