Catalog Number 1014252-120 |
Device Problems
Inflation Problem (1310); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number e2019001.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was performed to treat a 90% stenosed and heavily calcified de novo lesion in the anterior tibial artery (ata).A 2.X120mm armada 18 balloon catheter was prepared per the instructions for use with no damage noted.An attempt to inflate the balloon manually with a syringe was made; however, the balloon did not inflate to its nominal diameter and a distal outflow of contrast media was noted in the distal ata.The contrast mix ratio was 50:50.The balloon catheter was removed and inflated outside the patient anatomy; a leak was noted between the balloon material and the shaft.The procedure was successfully completed with a new unspecified armada 18 balloon catheter.The patient is doing well.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual analysis was performed on the returned device.A balloon rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the balloon interacted with the heavy lesion calcification causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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