Model Number UNK872 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Inflammation (1932)
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Event Type
Death
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Manufacturer Narrative
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Event date: in the last 3 years.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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Event Description
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It was reported that the patient experienced pancreatitis and died.Following a dialysis fistula thrombectomy procedure within the past 3 years, with an unknown angiojet catheter, a patient experienced pancreatitis and died.Additional information has been requested and is currently not available.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient experienced pancreatitis and died.Following a dialysis fistula thrombectomy procedure within the past 3 years, with an unknown angiojet catheter, a patient experienced pancreatitis and died.Additional information has been requested and is currently not available.
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Search Alerts/Recalls
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