Catalog Number 1012274-15 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/10/2018 |
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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the procedure was to treat an unknown lesion.During preparation, and before use, the trek rx 3.0 x 15 mm balloon dilatation catheter broke.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Device was discarded.The device was not returned for evaluation.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 incidents from this lot.The investigation determined the reported difficulty appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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