The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 peg kit was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2020, the entire peg tube had dislodged from the patient's stoma.Reportedly, the peg tube was not caught onto anything, it just dislodged.The patient was admitted to replace the dislodged peg tube.Consequently, the peg tube was replaced with a new peg tube on (b)(6) 2020.There were no reported patient complications as a result of this event.
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