Model Number IPN000252 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 07/31/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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This complaint was received via medwatch report (b)(4).It was reported that debris was noted within the intra-aortic balloon (iab) helium supply line.Black dots were seen inside the helium tubing concerning for blood from balloon puncture.The intra-aortic balloon pump (iabp) device was not alarming and patient's hemodynamics not affected at the time of event.The iabp dropped to 1:4.An attempt left iab removal with sheath over long guidewire with the intention of replacing sheath, but resistance was met with removal of the iab/sheath unit with distal third of balloon still in the femoral vessel.This was ultimately removed by the doctor.As a result, a new iab was placed in the right femoral artery.
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Event Description
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This complaint was received via medwatch report (b)(4).It was reported that debris was noted within the intra-aortic balloon (iab) helium supply line.Black dots were seen inside the helium tubing concerning for blood from balloon puncture.The intra-aortic balloon pump (iabp) device was not alarming and patient's hemodynamics not affected at the time of event.The iabp dropped to 1:4.An attempt left iab removal with sheath over long guidewire with the intention of replacing sheath, but resistance was met with removal of the iab/sheath unit with distal third of balloon still in the femoral vessel.This was ultimately removed by the doctor.As a result, a new iab was placed in the right femoral artery.
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Manufacturer Narrative
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Qn#(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab: blood in helium pathway is not able to be confirmed.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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