Model Number 0684-00-0295-05 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2022 |
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)(64.Device not returned.
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Event Description
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It was reported that prior to insertion of the intra-aortic balloon (iab), the iab membrane became unfolded and could not be inserted through the sheath.Another iab was then used.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The sheath was not returned for evaluation.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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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