Catalog Number B1060-150 |
Device Problems
Kinked (1339); Physical Resistance (2578); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/28/2017 |
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.Concomitant medical products: guide wire: radifocus 0.035" 180cm; guide catheter: destination 6f 45cm.The customer reported the device was discarded.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 lesion located in the superficial femoral artery with no tortuosity.Resistance was felt during advancement of a 6.0x150mm armada 35 balloon dilatation catheter (bdc) to the lesion and crossed successfully.The bdc was inflated twice at 6atm (total dilatation time was 600 seconds) without issues; however after the bdc was removed from the anatomy, the inner member of the balloon was observed to be kinked and stuck out from the balloon material.No deflation issue was reported, the balloon deflated completely prior to removal.No additional treatment was performed to the target lesion.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for evaluation.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.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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