BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939185401510 |
Device Problems
Kinked (1339); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/01/2016 |
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 manufacturer: returned product consisted of a coyote balloon catheter.There was blood in the inflation lumen and balloon.Microscopic examination and tactile inspection revealed numerous kinks in the shaft of the device.The balloon was loosely folded.Microscopic examination of the balloon presented no damage or irregularities.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the balloon wall 5.5cm proximal of the distal markerband.The balloon was microscopically examined and a pinhole in the balloon wall was revealed.Microscopic examination presented no irregularities in the balloon material that could have contributed to the damage.Microscopic examination and tactile inspection presented no damage or irregularities to the core wire.Microscopic examination presented no damage or irregularities to the markerbands.Microscopic examination presented no damage or irregularities to the bonds.Microscopic examination presented no damage or irregularities to the distal tip.Inspection of the remainder of the device, apart from the observed damage, presented no other damage or irregularities.No other issues were identified during the product analysis.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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Reportable based on device analysis completed on 29-apr-2016.It was reported that shaft kink occurred and crossing difficulties were encountered.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A 4.0mm x 150mm x 150cm coyote¿ balloon catheter was advanced for dilatation.However, the shaft was kinked and the device failed to cross the lesion.The procedure was completed with a non-bsc balloon catheter.No patient complications were encountered and the patient's status was good.However, returned device analysis revealed a balloon pinhole.
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