Model Number 7960 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Memory Loss/Impairment (1958)
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Event Date 06/20/2022 |
Event Type
Injury
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Event Description
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It was reported that an embolic stroke occurred.An impluse diagnostic guide catheter was selected for use in a coronary intervention procedure.The impluse took 4 mins to cross the valve.Eleven days post procedure, within the same month as the initial procedure, the patient experienced an embolic stroke requiring hospital treatment.No further patient complications were reported.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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B5: event description was corrected.B7: other relevant history was corrected.G1: mfg address line 1 (b)(6).
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Event Description
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It was reported that an embolic stroke occurred resulting in memory loss.On june 8, 2022, an impluse (5f) diagnostic guide catheter was selected for use in a coronary intervention procedure.On (b)(6) 2022 the patient experienced an embolic stroke resulting in memory loss.No further patient complications were reported.
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Search Alerts/Recalls
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