Catalog Number 22438-19 |
Device Problems
Break (1069); Product Quality Problem (1506)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/21/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical product: guide wire: amplatz.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.
|
|
Event Description
|
It was reported that the procedure was to treat a moderately calcified right subclavian artery that did not have tortuosity.A 190 cm emboshield nav6 embolic protection device (epd) was placed in the right internal carotid artery.However, a non-abbott guide wire that was in the subclavian artery damaged the tip of the epd filtration element.Therefore, the epd was removed without any issues and an unspecified stent was implanted in the right subclavian artery.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
Device codes: 1506 not labeled.Internal file number - (b)(4).Correction: device code 1069 removed.The product was not returned to abbott vascular for analysis.Return of the embolic protection system may have further aided the analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed since the lot number was not reported and the product was not returned to abbott vascular for analysis.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Search Alerts/Recalls
|