Catalog Number 1012447-12 |
Device Problems
Detachment Of Device Component (1104); Difficult To Position (1467)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/16/2018 |
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 was received.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 the procedure was to treat a non-tortuous, non-calcified right coronary artery.While advancing a 2.50 x 12mm nc trek balloon dilatation catheter (bdc), resistance was felt with the guide wire.The physician decided to stop and remove the device.During removal, the proximal shaft of the bdc snapped and broke on the physicians hand (outside of the anatomy).No resistance was felt during removal.The rest of the bdc was simply pulled out.Another nc trek was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported separation was confirmed.The reported difficulty positioning the device over the guide wire could not be replicated in a testing environment due to the condition of the returned device.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulty positioning the balloon dilatation catheter over the guide wire.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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