Catalog Number 0684-00-0567 |
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 01/10/2024 |
Event Type
malfunction
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Event Description
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It was reported that the intra-aortic balloon (iab) would not advance through the sheath.A new iab was opened and successfully advanced through the sheath.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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Complete initial report name: (b)(6) occupation: cathlab technician 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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N/a.
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Manufacturer Narrative
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The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter with the guide wire inside the inner lumen.The one-way valve and extender tubing were also returned.The sheath was not returned for evaluation.The one-way valve was vacuum tested and it held vacuum.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, extracorporeal and extender 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.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.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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