Catalog Number 1012453-08 |
Device Problems
Detachment Of Device Component (1104); Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2018 |
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 is expected to be returned for evaluation.It has not yet been received.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 an unknown lesion.The nc trek 4 x 8 mm balloon dilatation catheter was being advanced in the guiding catheter when the shaft kinked.When the delivery system was removed, it separated in two pieces, outside the patient.Another nc trek balloon dilatation catheter was used to successfully complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Visual and dimensional inspections were performed on the returned device.The separation and the kink were confirmed.The investigation determined the reported kink and separation 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 incidents from this lot.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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