The complainant was unable to provide the suspect device upn and 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 as it is implanted in the patient; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an endovive initial placement kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, on (b)(6) 2015, the peg tube was occluded.The patient is waiting for the peg/j tube replacement.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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