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Model Number 38275 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
No Code Available (3191)
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Event Date 08/10/2020 |
Event Type
Injury
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Event Description
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It was reported that the catheter broke.The totally occluded target lesion was located in the calcified left common iliac artery.Access to the lesion was from the right groin.A 4fr imager ii angiograhphic catheter was advanced over a v-18 guidewire.During the procedure, the imager embedded in the chronic total occlusion (cto).The physician tried backing out the device but experienced difficulty due to the cto.The v-18 wire was switched to a different wire to see if this would help.This was not successful.In attempts to pull the imager out from the cto, the imager catheter broke approximately 80mm from the distal end.The broken section was retrieved via snare and no fragments were left in the patient.There were no further patient complications and the patient was fine.It was possible that the device was kinked and broke at this location.
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Manufacturer Narrative
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Device evaluated by manufacturer: analysis showed that the device was separated approximately 11.5cm from the tip.There were multiple small bends and kinks located throughout the shaft.The catheter looked to be stretched, which would give the indication of tensile force.This damage is consistent with patient conditions such as a severely calcified, stenosed lesion and tortuous anatomy.The reported information stated that the device was imbedded in a total chronic occlusion.Tensile testing was performed on the returned unit by pulling approximately 84cm from the strain relief.Maximum tensile force was 7lbs.The minimum specification is 2.2lbs.This confirms the device met specification.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
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Event Description
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It was reported that the catheter broke.The totally occluded target lesion was located in the calcified left common iliac artery.Access to the lesion was from the right groin.A 4fr imager ii angiographic catheter was advanced over a v-18 guidewire.During the procedure, the imager embedded in the chronic total occlusion (cto).The physician tried backing out the device but experienced difficulty due to the cto.The v-18 wire was switched to a different wire to see if this would help.This was not successful.In attempts to pull the imager out from the cto, the imager catheter broke approximately 80mm from the distal end.The broken section was retrieved via snare and no fragments were left in the patient.There were no further patient complications and the patient was fine.It was possible that the device was kinked and broke at this location.
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Search Alerts/Recalls
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