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)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2021 |
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 returned device was connected to the tactisys quartz unit.The device did not meet specifications during shaft leak testing.Further investigation revealed that the shaft had been bent at the distal edge of electrode ring 4 and the shaft had been fractured at this location, consistent with the failed shaft leak test, fluid ingress proximal to electrode ring 3, fiber fracture in optical fibers 1-3, and with a loss of contact force during the procedure.The cause of the bent and fractured shaft is consistent with damage during use.
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Event Description
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This report is to advise of an event observed during analysis confirming device fracture and subsequent fluid leak.
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Search Alerts/Recalls
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