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Model Number C408646 |
Device Problems
Difficult to Insert (1316); Material Twisted/Bent (2981)
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Patient Problem
Vascular Dissection (3160)
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Event Date 01/07/2021 |
Event Type
Injury
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Event Description
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Related manufacturing ref: 3009600098-2021-00005.During the procedure, a dissection occurred when two catheters became kinked and failed to cross the proximal right coronary artery lesion.The first catheter went in the vessel wall.The catheter was replaced, but the second catheter was caught in the damage caused by the first catheter.The catheter was replaced with a non-abbott device and the dissection was noticed.A stent was implanted to repair the vessel and complete the procedure with no patient consequences.
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Manufacturer Narrative
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One dragonfly optis imaging catheter was received for evaluation.The results of the investigation concluded that the catheter had been kinked between the lens and the guidewire exit port.Functional testing revealed that the mini-rail measured 0.0155¿, which was within manufacturing specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event is consistent with the kink.The cause of the kink is consistent with damage during use.Based on the condition of the device and the information received from the field, the exact cause of the reported dissection remains unknown.
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Search Alerts/Recalls
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