Model Number H74939282302010 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at the time of event: 18 years or older.
(b)(4).
Device evaluated by mfr: the device has not been received for analysis.
Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
(b)(4).
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Event Description
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It was reported that balloon rupture occurred.
The 90% stenosed target lesion was located in the severely calcified superficial femoral artery.
A 3.
0mmx20mmx143cm nc quantum apex¿ balloon catheter was used to dilate the lesion.
The balloon was initially inflated at 8 atmospheres.
Upon the second inflation at 5 atmospheres for 5 seconds, the balloon ruptured.
The procedure was completed with a different device.
No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.
: returned product consisted of a coyote nc balloon catheter and a stopcock.
The balloon was loosely folded with blood in the balloon and inflation lumen.
Microscopic inspection and functional testing revealed a pinhole in the balloon material, 2mm proximal of the distal markerband.
There is no indication the device was inflated over rbp.
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 balloon rupture occurred.
The 90% stenosed target lesion was located in the severely calcified superficial femoral artery.
A 3.
0mmx20mmx143cm nc quantum apex¿ balloon catheter was used to dilate the lesion.
The balloon was initially inflated at 8 atmospheres.
Upon the second inflation at 5 atmospheres for 5 seconds, the balloon ruptured.
The procedure was completed with a different device.
No patient complications were reported.
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Search Alerts/Recalls
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