(b)(4).Evaluation conclusion codes: the complainant indicated that the device was disposed and 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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It was reported to boston scientific corporation that an endovive safety peg pull method was placed during an esophagogastroduodenoscopy (egd) with percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the pull wire on the end of the peg tube broke.The procedure was completed with this device.There were no reported patient complications as a result of this event.
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