Model Number 0684-00-0576-01 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2021 |
Event Type
malfunction
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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.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).Device not returned.
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Event Description
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It was reported that once the intra-aortic balloon (iab) was inserted and therapy was initiated, a fiber optic sensor failure occurred.The iab was removed and replaced.However, the second iab could not be advanced through the sheath.There was no patient harm or adverse event reported.This report is for the second iab.A separate report will be submitted for the first iab.
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Event Description
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N/a.
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Manufacturer Narrative
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Update device available for eval? from "yes" to "no." added type of investigation code - 4115 device discarded.The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).H3 other text : device not returned.
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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 (b)(6) 2019 to (b)(6) 2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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Search Alerts/Recalls
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