Catalog Number 0684-00-0575 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) insertion the customer could not get a negative pressure or advance iab through the sheath.The iab was replaced with a second iab and developed a leak after it was inserted for a few hours.A third iab was then inserted successfully.There was no reported injury to the patient.The date of the event is unknown.This submission is for the 1st iab used.
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Manufacturer Narrative
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The product was returned with the membrane loosely folded and blood on the exterior of the catheter.The sheath was not returned for evaluation.A kink was found in the catheter tubing approximately 34.5cm from the iab tip.- 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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Event Description
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It was reported that during intra-aortic balloon (iab) insertion the customer could not get a negative pressure or advance iab through the sheath.The iab was replaced with a second iab and developed a leak after it was inserted for a few hours.A third iab was then inserted successfully.There was no reported injury to the patient.The date of the event is unknown.This submission is for the 1st iab used.
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Search Alerts/Recalls
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