Date of event was approximated to (b)(6) 2018 as no event date was reported.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown at this time.(b)(4).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 safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure.The exact procedure date was unknown; however it was reported that it was placed a week before the event happened.According to the complainant, the patient went to the emergency room due to pain at the peg site.Patient also complained of leaking around the tube and the external bolster was tight against the skin.Ct scan was ordered and revealed that there was inflammation of the fat between the stomach and the skin.There was tenting of the gastric mucosa.The boston peg tube external bolster was extremely difficult to loosen, wherein it stretched the peg tube when trying to loosen the external bolster.They used two clamps, one of which was grasping the tube between the skin and the other clamp was used to grasp the external bolster which induced pain to the patient.
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