Catalog Number 1120225-18 |
Device Problems
Difficult To Position (1467); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The hi-torque bmw referenced in this report is filed under a separate medwatch report number.
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Event Description
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It was reported that the procedure was to treat a mildly tortuous and mildly calcified first diagonal artery.A 2.25 x 18 mm xience alpine stent delivery system could not advance over a balance middleweight (bmw) guide wire and the stent delivery system got stuck.The devices were removed as a single unit.The procedure was completed using new devices.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device was returned for analysis.The reported difficulty to position and the reported difficulty to remove were unable to be confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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