Catalog Number 0684-00-0497 |
Device Problems
Difficult to Insert (1316); Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/25/2020 |
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).
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Event Description
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It was reported that during insertion of an intra-aortic balloon (iab), the catheter was unable to pass through the sheath.Because of this, the balloon began to unfurl.Another iab was opened, but the same issue occurred.A third iab was opened and inserted successfully.This report is for the 1st iab.There was no reported injury to the patient.
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Manufacturer Narrative
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Additional information: section d - serial # changed to: (b)(6).The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.The one-way valve was also returned and still attached to the extracorporeal tubing.A deformed/flattened catheter tubing was observed.This deformation may occur if a vacuum is held with the one-way valve for an extended period of time, causing the catheter tubing to lose its round shape.The returned one-way valve was tested and it held vacuum.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A laboratory insertion test was unable to be performed due to the returned condition of the iab.The evaluation cannot confirm the reported problem due to the returned condition of the iab.We are unable to duplicate the clinical settings.A device and 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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Event Description
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It was reported that during insertion of an intra-aortic balloon (iab), the catheter was unable to pass through the sheath.Because of this, the balloon began to unfurl.Another iab was opened, but the same issue occurred.A third iab was opened and inserted successfully.This report is for the 1st iab.There was no reported injury to the patient.
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Manufacturer Narrative
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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 # (b)(4).
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Event Description
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It was reported that during insertion of an intra-aortic balloon (iab), the catheter was unable to pass through the sheath.Because of this, the balloon began to unfurl.Another iab was opened, but the same issue occurred.A third iab was opened and inserted successfully.This report is for the 1st iab.There was no reported injury to the patient.
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Search Alerts/Recalls
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