Catalog Number IAB-S840C |
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 01/23/2018 |
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 on a patient of (b)(6) in height an intra-aortic balloon (iab) was being placed.The md could not pass the spring wire guide (swg) through the central lumen of the balloon after the swg insertion via puncture.Considering its lumen was blocked and after changing to another balloon, it worked.The patient as reported did not require any medical or surgical intervention.Patient outcome: fine.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of tight over guidewire is confirmed.A kink was found on the central lumen, and as a result, guidewire resistance was experienced during functional testing.The root cause of the kink is undetermined but a potential cause is a result of customer handling.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
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Event Description
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It was reported that on a patient of 5.5ft in height an intra-aortic balloon (iab) was being placed.The md could not pass the spring wire guide (swg) through the central lumen of the balloon after the swg insertion via puncture.Considering its lumen was blocked and after changing to another balloon, it worked.The patient as reported did not require any medical or surgical intervention.Patient outcome: fine.
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Search Alerts/Recalls
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