Model Number M00566490 |
Device Problems
Defective Device (2588); Difficult to Advance (2920)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an endovive safety peg kit push method was inspected on (b)(6) 2020.According to the complainant, upon inspection of inventory a bulge was found in the peg tube.The exact location is unknown, however it was between the dilator tip portion and the bolster.Reportedly, this device was not used in a patient or procedure.
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Event Description
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It was reported to boston scientific corporation that an endovive safety peg kit push method was inspected on (b)(6) 2020.According to the complainant, upon inspection of inventory a bulge was found in the peg tube.The exact location is unknown, however it was between the dilator tip portion and the bolster.Reportedly, this device was not used in a patient or procedure.Additional information received on (b)(6) 2020: the bulge was found at the transition connector of the push tube.
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Manufacturer Narrative
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Additional information: b5 block h6 (device codes): problem code 2920 captures the reportable event of peg tube difficult to advance.Block h6 (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 mdr will be filed.
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Search Alerts/Recalls
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