Catalog Number IAB-06840-U |
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 06/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that an intra-aortic balloon (iab) was placed in a patient of 164cm in height via the right femoral artery.Difficulty was encountered when advancing the iab into the sheath.The medical doctor removed the catheter and replaced with another catheter to the same insertion site.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for analysis.The reported complaint of catheter stuck in sheath is not confirmed.The teflon sheath was removed from the iab without any damage found to the iab or any potential causes for difficulty.Both the sheath and iab bladder passed dimensional specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint will be monitored for any developing trends.
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Event Description
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It was reported that an intra-aortic balloon (iab) was placed in a patient of (b)(6)cm in height via the right femoral artery.Difficulty was encountered when advancing the iab into the sheath.The medical doctor removed the catheter and replaced with another catheter to the same insertion site.There was no report in patient death or complications.A report of delay in therapy but no harm caused to the patient.
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Search Alerts/Recalls
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