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
Entrapment of Device (1212); Material Frayed (1262)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 11/19/2021 |
Event Type
malfunction
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Event Description
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Related manufacturer ref: 3005334138-2021-00712.During an atrial fibrillation, when attempting to remove the mapping catheter from the introducer, it became stuck.It was then attempted to remove both the mapping catheter and introducer at the same time, but the two could not be removed.The incision was enlarged at the vascular site and the catheter and introducer were then able to be removed.Upon removal, both the catheter and introducer were noted to be torn and bent at the tips.The procedure was continued as the mapping portion was completed.
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Manufacturer Narrative
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One 8.5f swartz braided introducer sheath was received for evaluation.The sheath tubing and had been torn, bent and flared at the distal tip; the braided wires and marker band had been fractured at the tear location.The sheath hemostasis cap inside diameter measurement was within specifications and no anomalies were noted when a dilator from current inventory was inserted and withdrawn.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported withdrawal difficulty remains unknown.
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