Catalog Number IAB-05840-LWS |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problems
Congestive Heart Failure (1783); Low Cardiac Output (2501)
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Event Date 02/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).See also mdr #1219856-2017-00059.
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Event Description
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It was reported that the event involved a patient of 70 inches in height.The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the operating room (or).That evening, during therapy post insertion, the balloon ruptured and was removed by the medical doctor (md).The sheath remained in place.The patient was taken to cath lab on (b)(6) 2017 and a new iab was inserted via sheath.The length of time in use prior to event was less than 19 hours.There was an interruption in intra-aortic balloon pump (iabp) therapy for less than 11 hours.There was no reported patient death, injury or complications.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for analysis.The reported complaint of blood in helium pathway is confirmed.The iab bladder has a full thickness abrasion which allowed blood to enter the iab.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.No further action required.A device history report review was performed and it did not reveal any manufacturing related issues.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.Other remarks: please refer to mdr #1219856-2017-00059/(b)(4) related to this complaint.
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Event Description
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It was reported that the event involved a patient of (b)(6) inches in height.The intra-aortic balloon (iab) was inserted via sheath into the patient's right axillary artery on (b)(6) 2017 in the operating room (or).That evening, during therapy post insertion, the balloon ruptured and was removed by the medical doctor (md).The sheath remained in place.The patient was taken to cath lab on (b)(6) 2017 and a new iab was inserted via sheath.The length of time in use prior to event was less than 19 hours.There was an interruption in intra-aortic balloon pump (iabp) therapy for less than 11 hours.There was no reported patient death, injury or complications.
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Search Alerts/Recalls
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