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Model Number 24672 |
Device Problems
Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/23/2022 |
Event Type
Injury
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Event Description
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It was reported that balloon damage occurred.The target lesion was an area of in-stent restenosis located in the left iliac artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during introduction, the balloon was difficult to advance.The balloon was hooked by the stent and was damaged.Additionally, the physician found the dilation was not sufficient.The mustang balloon was removed from the patient and the procedure was completed by implanting another stent.There were no patient complications reported and the patient status was stable.
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Manufacturer Narrative
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B5.Describe event or problem- updated.
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Event Description
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It was reported that balloon damage occurred.The target lesion was an area of in-stent restenosis located in the left iliac artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during introduction, the balloon was difficult to advance.The balloon was hooked by the stent and was damaged.Additionally, the physician found the dilation was not sufficient.The mustang balloon was removed from the patient and the procedure was completed by implanting another stent.There were no patient complications reported and the patient status was stable.It was further reported that before usage of the mustang balloon catheter, the patient had an implanted stent.The mustang was advanced for dilation but was unable to pass the stent and the device was hooked by the stent.The device was removed and no intervention was involved in removing the device.On the following day, stenting was performed as dilatation was not sufficient.Although dilatation was not sufficient, there were no inflation or dilatation issues noted on the mustang balloon catheter.
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Search Alerts/Recalls
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