Catalog Number 1012451-12 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/13/2018 |
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 customer reported the device was discarded.Investigation is not yet complete.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 a lesion in the mildly tortuous, moderately calcified, proximal to mid, 90% stenosed obtuse marginal artery with a 3.50 x 12 mm nc trek rx balloon dilatation catheter (bdc).During advancement through the unspecified guiding catheter with no resistance noted, the mid shaft of the bdc separated.The point of separation was outside the anatomy; therefore, the separated portion was removed from the unspecified guiding catheter with no issues noted.A new 3.50 x 12 mm nc trek rx bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).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 operational context.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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