Catalog Number 0684-00-0575 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2017 |
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 during intra-aortic balloon (iab) catheter therapy that the physician found it difficult to pass the balloon through the sheath.There was no injury or harm to the patient.
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Manufacturer Narrative
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(b)(4).The product was returned with the membrane loosely folded and blood found on the exterior of the catheter and between the catheter and the sheath.The returned sheath was completely over the catheter tubing.The pressure and extender tubing were also returned.The returned sheath was measured and found to be within specification.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.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4); record # (b)(4).
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Event Description
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It was reported during intra-aortic balloon (iab) catheter therapy that the physician found it difficult to pass the balloon through the sheath.There was no injury or harm to the patient.
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Search Alerts/Recalls
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