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Model Number 24681 |
Device Problems
Break (1069); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2023 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during procedure, the balloon was broken.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable.
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Event Description
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It was reported that shaft break occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during procedure, the balloon was broken.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable.It was further reported that the balloon material itself broke, and not the shaft.The target lesion was 70% stenosed, non-tortuous, and non-calcified.
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Manufacturer Narrative
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B5 - describe event or problem: updated to include new information obtained.H6 - device codes: updated from break to material rupture.
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Manufacturer Narrative
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D4: lot number: updated from 0029642574 to 29458309.Device evaluated by mfr.: a charger device 14 atmospheres was received for analysis.As per the charger directions for use the catheter is compatible with a 0.035-inch (0.89 mm) guidewire.The investigator successfully loaded a boston scientific 0.035in guidewire through the charger device and removed it with no resistance encountered.No issues were identified with the device that could potentially have contributed to the complaint incident.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified that the balloon was not tightly folded and had been subjected to positive pressure.Blood note inside the balloon is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 2mm proximal from the proximal markerband.A visual and tactile examination identified no issues with the shaft of the device.A visual examination found no issues with the markerbands or tip of the device.
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Event Description
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It was reported that shaft break occurred.The stenosed target lesion was located in the iliac vein.A 12.0 x80, 75cm charger balloon catheter was advanced for dilation.However, during procedure, the balloon was broken.The procedure was completed with another of the same device.There were no patient complications reported, and the patient condition was stable.It was further reported that the balloon material itself broke, and not the shaft.The target lesion was 70% stenosed, non-tortuous, and non-calcified.
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Search Alerts/Recalls
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