Approximated based on the date the manufacturer became aware of the event.Additional physicians reported to be (b)(6).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.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a contour ureteral stent was used during a stent placement procedure in the ureter.The procedure date was not reported.According to the complainant, during the procedure and inside the patient when the physician attempted to remove the amplatz super stiff guidewire out of the contour ureteral stent, it was noticed that the stent was accordion/frayed at the distal end.The contour ureteral stent was removed.Another contour ureteral stent was used to successfully complete the procedure with the original amplatz super stiff guidewire.There were no patient complications reported as a result of this event.
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