Model Number DBEC-125 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 01/19/2022 |
Event Type
Injury
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Event Description
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During a procedure with a diamondback coronary orbital atherectomy device, a vessel perforation occurred in the left circumflex.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Additional information regarding the event, patient details and status and device information were requested but were not made available to csi.If additional information is received a supplemental report will be submitted.The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Csi id: (b)(4).
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Manufacturer Narrative
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The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Additional information regarding the event, patient details and status and device information were requested but were not made available to csi.If additional information is received a supplemental report will be submitted.The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.(b)(4).
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Event Description
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During a procedure with a diamondback coronary orbital atherectomy device, a vessel perforation occurred in the left circumflex.
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Search Alerts/Recalls
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