The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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 polaris ultra stent was removed during a stent removal procedure in the ureter.According to the complainant, during procedure, it was noticed that the renal side of the pigtail was bent, making it difficult to remove.It was also noticed that the stent was calcified.To remove the stent, transurethral lithotripsy (tul) was performed.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
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