Catalog Number 0684-00-0604 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Calcium Deposits/Calcification (1758); No Code Available (3191)
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Event Date 02/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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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After intra-aortic balloon (iab) was inserted in an ami (acute myocardial infarction) patient an iab optical sensor failure occurred.
Used inner lumen instead to continue therapy.
Mild calcification, tortuosity and moderate sclerosis were noted in the patient vessel.
The patient is in iab therapy continuously.
No patient injury was reported.
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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.
Two kinks were found on the catheter tubing approximately 52.
8cm and 73.
2cm from the iab tip.
The optical fiber was found to be broken at the kinked location of 52.
8cm.
The optical fiber was found to be broken, confirming the reported alarm.
It is difficult to determine when or how a break in the fiber optic occurs.
However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it.
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.
(b)(4).
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Event Description
|
After intra-aortic balloon (iab) was inserted in an ami (acute myocardial infarction) patient an iab optical sensor failure occurred.
Used inner lumen instead to continue therapy.
Mild calcification, tortuosity and moderate sclerosis were noted in the patient vessel.
The patient is in iab therapy continuously.
No patient injury was reported.
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Search Alerts/Recalls
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