Catalog Number 0909000050 |
Device Problems
Break (1069); Activation Failure (3270)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 09/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.
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Event Description
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This report summarizes 1 malfunction event in which the device broke during deployment inside the patient.The device was left in place, with no adverse consequence to the patient.
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Event Description
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This report summarizes 1 malfunction event in which the device reportedly would not expand or deploy.1 event had no known impact or consequences to the patient.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 1 previously reported event is included in this follow-up record.Product return status 1 device was not available for evaluation.H3 other text : device not returned.
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Search Alerts/Recalls
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