Catalog Number 0684-00-0575 |
Device Problems
Unraveled Material (1664); Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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.(b)(4).
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Event Description
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It was reported that the intra-aortic balloon (iab) could not be advanced through the sheath because it became unfurled.A new iab was inserted successfully to continue therapy.There was no reported injury to the patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) could not be advanced through the sheath because it became unfurled.A new iab was inserted successfully to continue therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The sheath was not returned for evaluation.- a laboratory insertion test was unable to be performed due to the membrane being unfurled.- the technician then attempted to insert a laboratory 0.025¿ guide wire through the inner lumen of the returned iab and was successful.- 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 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.(b)(4).
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Search Alerts/Recalls
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