Model Number 24628 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/02/2020 |
Event Type
Injury
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Event Description
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It was reported that the balloon failed to deflate and was difficult to remove.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for a percutaneous transluminal angioplasty (pta) of shunt anastomosis.Successful dilation of the lesion was performed using the device.Vacuum was applied to remove from the patient.The balloon was not folded back into original position and was unable to be removed from the patient.One of the cutting balloon blades became stuck at the tip of the non-bsc 6f sheath.The balloon and sheath were surgically removed.The patient's status was fine.
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Manufacturer Narrative
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Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.It was noted that approximately 4mm of the proximal end of one of the blades was lifted distally from the balloon material.The remaining 16mm of the blade and blade pad remained bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon and inflation lumen of the device were noted to have blood inside them which is evidence of a device leak.A microscopic examination identified a balloon pinhole located approximately 10mm distal of the proximal balloon sleeve.An examination of the balloon material and markerbands identified no issues.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that the balloon failed to deflate and was difficult to remove.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for a percutaneous transluminal angioplasty (pta) of shunt anastomosis.Successful dilation of the lesion was performed using the device.Vacuum was applied to remove from the patient.The balloon was not folded back into original position and was unable to be removed from the patient.One of the cutting balloon blades became stuck at the tip of the non-bsc 6f sheath.The balloon and sheath were surgically removed.The patient's status was fine.It was further reported that there was 70% stenosis and mild calcification of the shunt.
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Search Alerts/Recalls
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