ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER
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Model Number 407451 |
Device Problems
Flaked (1246); Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/18/2022 |
Event Type
malfunction
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Event Description
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During atrial fibrillation procedure, skiving was noted.After making the transseptal procedure with the sheath and the brk needle, resistance was encountered and when the needle was removed pieces of scraped substance of the dilator with the brk needle exited from the tip of the dilator.The sheath set was replaced and the procedure was completed with no adverse consequences to the patient.
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Manufacturer Narrative
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Additional information g3, h2, h3, h6.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 event of resistance and flaking while removing the needle from the sheath could not be conclusively determined.
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Search Alerts/Recalls
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