Catalog Number 0684-00-0605 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Event site postal code: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported that shortly after the insertion of the intra-aortic balloon (iab) the attached 7.5fr sheath side arm was separated from the sheath body even though it was not pulled.Since the iab catheter had already been inserted, the sheath could not be replaced, so it was tied and fixed with a thread and therapy was continued.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-2019 to oct-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Manufacturer Narrative
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Device discarded - a getinge representative reported that the involved intra-aortic balloon was discarded at the facility, and will no longer be returned for investigation.
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Event Description
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N/a.
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Search Alerts/Recalls
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