Catalog Number 1012270-15 |
Device Problems
Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/13/2018 |
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 customer reported the device is not returning.Investigation is not yet complete.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 on (b)(6) 2018, pre-dilatation was performed, and an unspecified stent was implanted.Intravenous ultrasound (ivus) was performed and it was noted that the stent was mal-apposed.The 2.0 x 15 mm mini trek dilatation catheter advanced, but did not cross the lesion due to patient anatomy.The proximal delivery catheter shaft separated at a location outside the patient anatomy and was easily removed.The stent mal-apposition was treated with a 2.0 x 15 mm mini trek dilatation catheter.There was no reported adverse patient effect or a clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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Device codes: 2889 labeled.Internal file number - (b)(4).Correction: device available for evaluation.Device code 1562 - labeled - removed.Evaluation summary: visual inspection was performed.The reported kink was not confirmed as there was no kink in the proximal shaft.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported failure to advance appears to be related to circumstance of the procedure; however, a conclusive cause for the reported kink could not be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Event Description
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Subsequent to the initial 30-day medwatch report, the following information was received: the device was able to initially cross the target lesion and was inflated.However, the device was used at a second lesion and was unable to cross.The proximal shaft kinked.As the kink was at a location outside the patient anatomy, the device was easily removed.The device did not separate, as originally reported.Although the device was not separated, as was originally reported, this event has been reported; therefore, this event will remain reportable.No additional information was provided.
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Search Alerts/Recalls
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