PHILIPS IMAGE GUIDED THERAPY CORPORATION ANGIOSCULPT EVO RX PTCA SCORING BALLOON CATHETER WITH HYDROPHILIC COATING; CATHETER, PTCA, CUTTING/SCORING
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Model Number 2200-2010-B |
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 02/26/2024 |
Event Type
Injury
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Event Description
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The angiosculpt device was used in a coronary procedure.During removal, a dissection occurred in the proximal section of the lad artery.An nc balloon and stent was used to complete the procedure.This adverse event is being submitted due to the dissection, requiring stent placement.
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Manufacturer Narrative
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Block a: the patient''s dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.Block b6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Block h3: the angiosculpt device was discarded by the facility, thus no returned product investigation was performed.Block h6: per the ifu, dissection is listed as a possible adverse effect of the procedure.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
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Manufacturer Narrative
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Block a: patient information received- patient''s dob or age at time of event, gender, weight, ethnicity, and race.Blocks b6/b7: received- relevant tests/laboratory data and medical history.Block d10: received- concomitant medical products: guidewire, introducer sheath, and guide catheter.
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Search Alerts/Recalls
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