Catalog Number A2020-120 |
Device Problems
Material Rupture (1546); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the procedure was to treat a de novo lesion located in the heavily tortuous, heavily calcified distal posterior tibial artery.The 2.0 x 120 mm armada 14 balloon catheter was advanced with resistance felt, due to the heavy calcium in the vessel.When the balloon was inflated for a second time the balloon ruptured at 14 atmospheres.The balloon was replaced with another same size armada 14 balloon catheter which was used successfully without any further issues.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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Manufacturer Narrative
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Internal file number - (b)(4).Evaluation summary: visual and functional inspection were performed on the returned device.The reported balloon rupture was confirmed.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.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 similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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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