It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure.Procedure date is unknown.According to the complainant, during the procedure, the peg tube was stuck while it was pulled through the abdomen.The peg tube was not easily sliding through the stoma and a lot of force had to be used to pull it out.The physician felt that the dilating tip was not smooth and there was a slight ridge that gets the peg tube stuck.Reportedly, the incision size is appropriate (exact size unknown.) 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 okay.
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Patient's exact age is unknown; however, it was reported that the patient was under 18 years old.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Reported event of peg tube difficulty placing/retracting.The complainant indicated that the device will not be returned for evaluation; 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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