Related manufacturer reference: 3005334138-2020-00235, 3005334138-2020-00261, 3008452825-2020-00330.During a procedure, resistance was noted while trying to advance the brk needle.Force was needed to advance the device.The sheath and needle were replaced, and again the issue was noted.The devices were replaced a third time and resolution was found to complete the procedure.There were no patient consequences.No additional access site was required, however a clinically significant delay of 20-30 minutes was noted.
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Additional information: d10, g4, g7, h2, h3, h6, h10.One swartz¿ braided transseptal guiding introducer, sl1¿, 81 cm length, 8.5f was received for investigation.No functional anomalies were noted when the brk needle/stylet assembly was advanced through an 8.5f sl1 dilator/sheath assembly from current inventory.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported insertion difficulty remains unknown.
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