ST. JUDE MEDICAL, INC. AMPERE¿ RF ABLATION GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER
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Model Number H700488 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2022 |
Event Type
malfunction
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Event Description
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During an af procedure, the positional information display on the tacticath se was unusual and unable to be use clinically.The geometry and mapping were performed with other catheters without issue, however it was not moving on the ensite side when the tacticath se was inserted into the heart.The catheter was exchanged, the respiratory correction was retaken, revalidated, all devices including the dws, amplifier, and ampere generator, were power cycled, connections were rechecked, but the issue persisted.The ampere generator was replaced with a non-abbott product and the procedure was completed with no adverse consequences to the patient.During inspection at nihon kohden tsurugashima office after returning from the medical facility, the recording system was used to confirm the issue, but the reported issue was not reproduced.
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Manufacturer Narrative
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Additional information: g3, g6, h2, h3, h6 the results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.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.
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Manufacturer Narrative
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Additional information: g3, g6, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the provided log files revealed no functional anomalies with the ampere and no errors could be seen for the reported event date.Based on the information received, the cause of the reported incident could not be determined.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.
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