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Model Number 407200 |
Device Problem
Difficult to Insert (1316)
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Patient Problems
Cardiac Perforation (2513); Thrombosis/Thrombus (4440)
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Event Date 03/18/2024 |
Event Type
Injury
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Event Description
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Manufacturing ref: 3005334138-2024-00108.During an atrial fibrillation procedure, a sheath was fractured, and a tamponade and thrombus occurred requiring a pericardiocentesis.After inserting the sheath into the patient, there was difficulty passing the transseptal needle.The sheath and needle were removed, and it was noted that the sheath was fractured.The sheath was replaced and a new transseptal puncture was attempted.However, a tamponade was then noted in the right atrium close to the septum.It was also noted that the sheath was not fixed well to the septum.The thrombus was seen through the transesophageal echocardiogram where the procedure was interrupted.A pericardiocentesis was performed, stabilizing the patient.The patient was then taken to the icu for follow-up.A transesophageal echocardiogram was performed before the procedure, but no thrombus was noted.
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Manufacturer Narrative
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Additional information: g3, h2, h3, h6, h11 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 sheath fracture, tamponade, and thrombus could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Search Alerts/Recalls
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