Model Number H74939147301010 |
Device Problems
Difficult to Remove (1528); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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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 catheter removal difficulties were encountered and balloon tear occurred.
A 3.
0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.
However during withdrawal, a tear was noted on the balloon and the device was sectioned on the holder.
The guide and the balloon were removed from the patient.
No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter with an unidentified guide wire still inserted.
The balloon was loosely folded.
There was contrast in the inflation lumen.
Device analysis determined the condition of the returned device was consistent with the complaint incident.
The outer shaft, inner shaft, balloon and tip were microscopically examined.
There were numerous hypotube kinks.
There was tip damage.
The wire lumen inside the balloon was buckled.
The shaft was completely separated 134.
5cm from the hub.
The fracture faces were stretched prior to separation.
Functional testing for balloon leak through inflation could not be conducted due to the shaft separation.
Visual inspection of the balloon did not reveal any damages.
The inner and outer lumen was torn at the exit notch and could contribute to the balloon leak.
The guide wire was successfully removed from the distal portion of the detached catheter.
The guide wire was separated 27cm from the tip.
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
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It was reported that catheter removal difficulties were encountered and balloon tear occurred.
A 3.
0mm x 100mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation.
However during withdrawal, a tear was noted on the balloon and the device was sectioned on the holder.
The guide and the balloon were removed from the patient.
No patient complications were reported.
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Search Alerts/Recalls
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