Catalog Number 1003330 |
Device Problems
Leak/Splash (1354); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2017 |
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.The four additional guide wire accessory kit with copilots referenced are being filed under separate medwatch reports.
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Event Description
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Reportedly, it was stated that five guide wire accessory kit with copilots had bad rotation.Additionally, the copilots leaked.The procedure was successfully completed with a new copilot.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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Internal file number (b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The reported leak and difficulty turning the rotator was not confirmed.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 revealed no indication of a lot specific product issue.The was unable to confirm the reported difficulty.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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