Model Number 00884450263150 |
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 11/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during a procedure, the clinician had intended to puncture the septum but had inadvertently punctured the aorta instead.The patient required surgical treatment.The clinician stated there was no device failure and that it was solely due to use error.No additional patient consequence to report.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
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Search Alerts/Recalls
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