Model Number H7493912420300 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that shaft break occurred.
A 20mm x 3.
00mm nc quantum apex¿ balloon catheter was advanced through the guide catheter to dilate the lesion.
However, the device was stuck to the guide catheter and blood came out of the proximal end.
The device was eventually removed, however it was noted that the 60cm of the distal tip and the balloon of the device were still in the guide catheter.
Another balloon was then advanced and fixed the remaining half of the nc quantum apex¿ balloon catheter to the wall of the guide catheter.
Both of the balloon catheter and guide catheter were slowly pulled out and were completely removed from the patient.
The procedure was completed with another of the same device.
No patient complications were reported and no harm to the patient.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a nc quantum apex balloon catheter.
The balloon was tightly folded.
There was contrast in the inflation lumen.
There was blood in between balloon folds.
The outer shaft, inner shaft, balloon and tip were microscopically examined.
The hypotube shaft was completely separated 62cm from the hub.
The fracture faces were oval as if kinked prior to separation.
There were numerous hypotube kinks.
There was tip damage.
There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.
The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.
(b)(4).
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Event Description
|
It was reported that shaft break occurred.
A 20mm x 3.
00mm nc quantum apex¿ balloon catheter was advanced through the guide catheter to dilate the lesion.
However, the device was stuck to the guide catheter and blood came out of the proximal end.
The device was eventually removed, however it was noted that the 60cm of the distal tip and the balloon of the device were still in the guide catheter.
Another balloon was then advanced and fixed the remaining half of the nc quantum apex¿ balloon catheter to the wall of the guide catheter.
Both of the balloon catheter and guide catheter were slowly pulled out and were completely removed from the patient.
The procedure was completed with another of the same device.
No patient complications were reported and no harm to the patient.
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Search Alerts/Recalls
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