During a premature ventricular contractions procedure, after mapping was completed, it was noted that the tactisys quartz units did not power on, so the case was stopped because of inability to proceed without contact catheters.
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Additional information confirmed that this event was already reported via manufacturing ref number: 2184149-2023-00247.Corrected information: b5, g3 additional information: d9, g3, h2, h3, h6 one tactisys¿ quartz was received for analysis.Visual inspection revealed the input, output connectors and controls appeared to be free of physical damage.The quartz was powered on and audible beeps were observed.This indicates the quartz successfully booted and communication was established.A known-good catheter was connected, and valid contact force was observed.A fiso diagnostic verified all fiso compact module signals were within specifications.The field reported event was not reproduced as the quartz was left-on for an extended period and no anomaly was observed.Communication and valid contact force were maintained.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the reported failure to power up and subsequent cancellation could not be conclusively determined as the returned tactisys functioned as anticipated throughout the investigation.
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