BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number H74939186150410 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant name: (b)(6).(b)(4).Returned device consisted of a coyote balloon catheter and a guide wire.The balloon was loosely folded and the guide wire was loaded into the coyote device.The tip, hypotube, inner shaft and outer shaft were microscopically inspected.Inspection revealed inner shaft damage (buckling) for 41 mm located inside the balloon material, balloon damage (bunching) and tip damage (misshapen/bunched up).The inner diameter of the shaft could not be measured, as the guide wire could not be separated from the coyote.Microscopic inspection found the remainder of the device free of damage.Functional testing of the device could not be done, due to the condition of the returned device.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
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Event Description
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Same case as mdr# 2134265-2018-01393.Reportable based on analysis completed on 05-feb-2018.It was reported that the device was difficult to advance.The target lesion was located on the right side below the knee.A 1.5mmx40mmx150cm coyote¿ balloon catheter was introduced over a v-14¿ controlwire® through a 5f 45cm non-bsc introducer sheath.The balloon wasn't inflated in the sheath.The catheter and wire could not be advanced from the sheath and were both removed.The procedure was completed with another of the same device.No patient complications were reported and the patient is fine.However device analysis revealed catheter was froze on wire.
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Manufacturer Narrative
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Corrected: (b)(4).Corrected: device evaluated by mfr (below).Device evaluated by mfr originally reported as: returned device consisted of a coyote balloon catheter and a guide wire (related device, mdr# 2134265-2018-01393).The balloon was loosely folded and the guide wire was loaded into the coyote device.The tip, hypotube, inner shaft and outer shaft were microscopically inspected.Inspection revealed inner shaft damage (buckling) for 41 mm located inside the balloon material, balloon damage (bunching) and tip damage (misshapen/bunched up).The guide wire could not be separated from the coyote.Microscopic inspection found the remainder of the device free of damage.Functional testing of the device could not be done, due to the condition of the returned device.Additional investigation revealed the following; since the guidewire could not be removed from the coyote catheter, both devices were sent to another bsc investigation site for analysis of the guidewire.During the analysis, the wire was able to be removed from the balloon catheter.The coyote balloon catheter was sent back to maple grove for further analysis.Additional analysis of the coyote balloon catheter found the device was returned without the related guidewire and was reviewed again.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.The inner shaft is buckled in numerous locations under the balloon.The damage is consistent with the damage that is seen caused by use of a guidewire.Functional testing was completed using a thruway.014 guidewire.The thruway guidewire was inserted through the distal tip and could not advance due to the damage.(b)(4).
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Event Description
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Same case as mdr# 2134265-2018-01393.Reportable based on analysis completed on 05-feb-2018.It was reported that the device was difficult to advance.The target lesion was located on the right side below the knee.A 1.5mmx40mmx150cm coyote¿ balloon catheter was introduced over a v-14¿ controlwire® through a 5f 45cm non-bsc introducer sheath.The balloon wasn't inflated in the sheath.The catheter and wire could not be advanced from the sheath and were both removed.The procedure was completed with another of the same device.No patient complications were reported and the patient is fine.However device analysis revealed catheter was froze on wire.
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