ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8.; INTRODUCER, CATHETER
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Model Number 406849 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2022 |
Event Type
malfunction
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Event Description
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During a left atrial appendage occlusion procedure, following the transseptal puncture, a thread was observed on the introducer in the left atrium on trans-esophageal echocardiogram.An activated clotting time was performed and the sheath was aspirated in order to pull the piece back into the introducer that appeared to be on the tip.The part was then thought to be a part of plastic from the sheath.The activated clotting time was 280 and no clot was detected.A stylet was used with the needle, however, the needle was pre-shaped prior to insertion.The introducer was exchanged and the procedure was completed with no adverse consequences to the patient.There were no insertion difficulties noted with the needle.The piece of material was not free floating in the left atrium and was only on the tip.It was not able to be confirmed whether this was the only plastic thread from the incident.
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Manufacturer Narrative
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Additional information: d9, g3, h2, h3.One 8.5f fast-cath introducer sheath was received for evaluation.Visual inspection revealed the sheath distal tip had been split and ben and was kinked 7.66¿ proximal to the distal tip.The sheath had been split and bent at the distal tip; however, no missing material was noted.Information from the field stated that the needle had been pre-shaped.The brk needle instructions for use (ifu) states, ¿do not alter this device in any way.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported "thread was observed on the introducer" could not be conclusively determined.
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