Catalog Number IAB-S840C |
Device Problems
Occlusion Within Device (1423); Aspiration Issue (2883)
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Patient Problems
Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)
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Event Date 04/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: (b)(4).
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Event Description
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It was reported that the event occurred in the cath lab.The medical doctor found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless.The iab was placed in the "arcus aorta".The medical doctor could not aspirate the central lumen and the md decided to remove the iab.According to the report the md found it difficult to insert the wire into the central lumen.There was no reported patient death or injury.There was a reported complication of being hemodynamically not stable.The intervention required was a ptca (percutaneous transluminal coronary angioplasty).The patient received a competitor's iab via the same insertion site successfully.
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Manufacturer Narrative
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Concomitant medical products: (b)(4).This mdr was submitted in error and is a duplicate of 1219856-2016-00113 initially submitted on (b)(6) 2016.
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Event Description
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It was reported that the event occurred in the cath lab.The md found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless.The iab was placed in the "arcus aorta".The md could not aspirate the central lumen and the md decided to remove the iab.According to the report the md found it difficult to insert the wire into the central lumen.There was no reported patient death or injury.There was a reported complication of being hemodynamically not stable.The intervention required was a ptca (percutaneous transluminal coronary angioplasty).The patient received a competitor's iab via the same insertion site successfully.
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Manufacturer Narrative
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Concomitant medical products: (b)(4).No product was returned for evaluation.A device history record (dhr) review was unable to be completed.No lot number was reported.The lot numbers at this account are unable to be retrieved at this time.When the dhr is completed, the complaint will be updated accordingly.The reported complaint of unable to aspirate/flush is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.If the sample is returned at a later date, a full investigation will be completed.
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Event Description
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It was reported that the event occurred in the cath lab.The md found it difficult to thread the iab over the guide wire however, the intra- aortic balloon catheter (iab) was inserted via the patient's right femoral artery sheathless.The iab was placed in the "arcus aorta".The md could not aspirate the central lumen and the md decided to remove the iab.According to the report the md found it difficult to insert the wire into the central lumen.There was no reported patient death or injury.There was a reported complication of being hemodynamically not stable.The intervention required was a ptca (percutaneous transluminal coronary angioplasty).The patient received a competitor's iab via the same insertion site successfully.
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Search Alerts/Recalls
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