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 initial placement peg kit was used during a percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.According to the complainant, the patient visited the hospital due to buried bumper syndrome.With the help of a thick and thorough guidewire, the tube was pushed inside.Reportedly, the skin plate should be loose a week after and the top of the triangle should be under the mark sign.The tube should be slightly fixated to prevent bending of the tube and tube should be moveable both inside and outside.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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