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).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 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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(b)(4).The device was returned to abbott vascular (av) and analysis confirmed the reported difficulty in rotating the connection portion.The device was pressurized to 400 psi and no leaks were detected.Av reviewed the lot history record and there were no manufacturing nonconformities found with this lot.Additionally, a review of the complaint history identified one similar incident from this lot.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the devices performance with regards to the difficulty rotating the connection was not related to a manufacturing issue, but due to normal variation found in manufacturing.The performance of these devices will continue to be monitored.
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Search Alerts/Recalls
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