Model Number 0684-00-0296-01 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: operations coordinator.Event site full name: (b)(6) hospital.The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).
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Event Description
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It was reported that while prepping for insertion, the customer noticed a tear in the intra-aortic balloon (iab).A second iab was then opened, but the membrane was unfurled and it could not be inserted through the sheath.Neither of the iabs had been inserted into the patient.A third iab was inserted successfully.There was no patient harm or adverse event reported.This report is for the second iab in this event.A separate report has been submitted for the first iab under mfg report number 2248146-2022-00509.
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Manufacturer Narrative
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Complaint record id # (b)(4).
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded and the one-way valve attached.No blood was visible on the catheter.No tear or damage was observed on the returned iab.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
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Search Alerts/Recalls
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