Catalog Number 1013069-12 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The traveler rx device 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 tortuous, mildly calcified mid left anterior descending artery that was 75% stenosed.After a non-abbott guide wire successfully crossed, a 3x12mm traveler balloon was advanced and pre-dilated the lesion once at around 12 atmospheres for 20 seconds.The balloon was attempted to be deflated but it was difficult.Around 15 to 20 seconds were held negative to attempt to deflate the balloon.After a prolonged period of time, the balloon ultimately deflated.Then a 3.5x24mm non-abbott stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was confirmed.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 was unable to determine a conclusive cause for the reported deflation issue.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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