BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939135204010 |
Device Problems
Failure to Advance (2524); Catheter (3038)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/10/2018 |
Event Type
Malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
(b)(4).
Device evaluated by mfr: returned product consisted of a coyote es balloon catheter.
The balloon was loosely folded.
Te outer shaft, inner shaft, balloon and tip were microscopically examined.
There are numerous hypotube and shaft kinks.
The balloon has a pinhole at the distal markerband.
Inspection of the remainder of the device presented no other damage or irregularities.
The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.
(b)(4).
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Event Description
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Reportable based on device analysis completed on 10-aug-2018.
It was reported that crossing difficulties were encountered.
The target lesion was located in the superficial femoral artery.
A 2mm x 40mm x 145cm coyote¿ es balloon catheter was advanced for pre-dilatation.
However, the device failed to cross the lesion despite several attempts.
The procedure was completed with a non-bsc device.
No patient complications were reported and the patient's status was stable.
However, returned device analysis revealed balloon pinhole.
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