Model Number 23375 |
Device Problem
Material Rupture (1546)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in the left common iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was introduced for 2-3 inflations and removed.When the balloon was reinserted to post-dilate a wallstent, the balloon ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was completely removed and a 14-6/5.8/75 xxl vascular balloon catheter was introduced to post dilate the stent.Inflations were completed and injection was done.When the balloon was reinserted for another dilation, it also ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was removed and the procedure was completed.There were no patient complications reported.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in the left common iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was introduced for 2-3 inflations and removed.When the balloon was reinserted to post-dilate a wallstent, the balloon ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was completely removed and a 14-6/5.8/75 xxl vascular balloon catheter was introduced to post dilate the stent.Inflations were completed and injection was done.When the balloon was reinserted for another dilation, it also ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was removed and the procedure was completed.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr: a xxl/14-6/5.8/75 was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located 12mm proximal from the proximal markerband.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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