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Model Number 24674 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Event Description
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It was reported that balloon leak occurred.The stenosed target lesion was located in the central vein.A 12.0 x 80, 75cm mustang balloon catheter was advanced for pre-dilation.However, after introducing the balloon through the guide wire and being prepared for dilation, it was found out that the balloon was leaking liquid and there was no pressure on the pressure pump.The physician checked the balloon and found out that it was damaged.There was no visible pinhole noted in either the shaft or the balloon.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
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Event Description
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It was reported that balloon leak occurred.The stenosed target lesion was located in the central vein.A 12.0 x 80, 75cm mustang balloon catheter was advanced for pre-dilation.However, after introducing the balloon through the guide wire and being prepared for dilation, it was found out that the balloon was leaking liquid and there was no pressure on the pressure pump.The physician checked the balloon and found out that it was damaged.There was no visible pinhole noted in either the shaft or the balloon.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
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Manufacturer Narrative
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A mustang 12.0 x 80, 75cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 5mm proximal of the proximal balloon markerband.From the partial circumferential tear the balloon was also torn longitudinally for approximately 90mm distally.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
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Search Alerts/Recalls
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