It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy placement procedure.Procedure date is unknown.According to the complainant, during the procedure, the peg tube was difficult to pull through the stoma site.Reportedly, the customer is concerned with the pull wire section of the device.The procedure was completed with this endovive safety peg kit pull method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Reported event of peg tube difficulty placing/retracting.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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