Model Number M00566460 |
Device Problems
Break (1069); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/10/2014 |
Event Type
malfunction
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-01596 and 3005099803-2014-01597 for the other associated device information.It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2014.According to the complainant, during the procedure, they had difficulty advancing the peg tube.The loop on the end of the peg tube broke.A second endovive safety peg kit pull method was used, however, the loop at the end of the peg tube also broke.Nothing fell inside the patient.It was reported that the incision size was 2-3cm and the patient had a tortuous anatomy.The procedure was completed with a third 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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Manufacturer Narrative
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Reported event of peg tube loop wire broke.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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Manufacturer Narrative
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Reported event of peg tube difficulty placing/retracting.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-01596 and 3005099803-2014-01597 for the other associated device information.It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2014.According to the complainant, during the procedure, they had difficulty advancing the peg tube.The loop on the end of the peg tube broke.A second endovive safety peg kit pull method was used, however, the loop at the end of the peg tube also broke.Nothing fell inside the patient.It was reported that the incision size was 2-3cm and the patient had a tortuous anatomy.The procedure was completed with a third 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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Search Alerts/Recalls
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