Catalog Number 1013152-15 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The nc traveler is currently not commercially available in the us; however, it is similar to a device sold in the us.
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Event Description
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It was reported that the procedure was to treat a mildly calcified, mildly tortuous, 90% stenosed, de novo, mid left circumflex artery (mlcx) lesion.A 2.75x15mm nc traveler balloon dilatation catheter (bdc) was advanced to the lesion and inflated one time, to 9 atmospheres (atm) when the balloon ruptured.The device was simply removed.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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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 similar incidents and/or complaints from this lot.The investigation determined the reported complaint 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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