VENUSA DE MEXICO S.A. DE C.V. TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number PN-004 075 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Electrical Shorting (2926)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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One 75 mm tacticath quartz contact force ablation catheter was received for evaluation.Optical fibers 1-3 no longer met specifications for optical properties and no contact force was displayed when the catheter was connected to the tactisys quartz unit.Error messages for optical signal loss and thermocouple signal loss were observed.The device did not meet specifications during a shaft leak test and an irrigation leak test.Additionally, multiple short circuits were detected.Further investigation revealed the pi irrigation tubing had been fractured in two places at the distal end of the catheter, consistent with the failed shaft leak and irrigation leak tests, fluid ingress, the observed short circuits, and a loss of contact force during the procedure.Additionally, optical fiber 3 and the red thermocouple 2 (tc2) wire were noted to be fractured at the distal end of the device, also consistent with the reported loss of contact force.
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Event Description
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This report is to advise of an event observed during analysis confirming a leak, fracture, and short circuits.
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Search Alerts/Recalls
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