ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 12; INTRODUCER, CATHETER
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Model Number 406306 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2021 |
Event Type
malfunction
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Event Description
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During a supraventricular tachycardia ablation procedure, the non abbott catheter was difficult to insertion into the hemostasis valve following insertion into the patient which caused a delay.An attempt to insert another non-abbott catheter did not resolve the issue.The sheath set was replaced and the procedure was completed with no adverse consequences to the patient.No additional femoral vein puncture was required for replacing the sheath.
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Manufacturer Narrative
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Additional information: g3, h2, h3 the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported insertion difficulties and subsequent delay remain unknown.
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