Model Number UNK518 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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 device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy placement procedure.Procedure date is unknown.According to the complainant, the physician reported the peg tube gets stuck at the transition zone between the hard and soft plastic when trying to place the device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The complainant reported that the device was not expired.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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Event Description
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It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy placement procedure.Procedure date is unknown.According to the complainant, the physician reported the peg tube gets stuck at the transition zone between the hard and soft plastic when trying to place the device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information as of october 4, 2016.Reportedly, there was no visible damage noted on the device and the procedure was completed with this endovive standard peg kit push method.
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Search Alerts/Recalls
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