Catalog Number M0032072112200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 07/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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The subject device was disposed of at the hospital.
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Event Description
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It was reported that percutaneous transluminal angioplasty (pta) was performed with the subject device and vessel dissection of the internal carotid artery occurred.Therefore a stent was deployed and the procedure was completed with no consequences to the patient.
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.However, vessel dissection is a known risk associated with endovascular procedures and is listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
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Event Description
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It was reported that percutaneous transluminal angioplasty (pta) was performed with the subject device and vessel dissection of the internal carotid artery occurred.Therefore a stent was deployed and the procedure was completed with no consequences to the patient.
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Search Alerts/Recalls
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