The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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 standard peg kit pull method was placed during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2013.According to the complainant, they noted black spots on the peg tube.In (b)(6) 2016, they noted buried bumper syndrome and the presence of granuloma in the peristomal area.The device remains in use.There were no patient complications reported as a result of this event.The patient's condition was reported to be "unchanged".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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