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Model Number SGC0701 |
Device Problems
Difficult or Delayed Positioning (1157); Failure to Advance (2524); Unintended Movement (3026)
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Patient Problems
Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 12/14/2021 |
Event Type
Death
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Manufacturer Narrative
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The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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This is filed to report unintended movement of the steerable guide catheter (sgc), pericardial effusion, cardiac tamponade, atrial perforation requiring surgical intervention and death.It was reported that this was a mitraclip procedure performed (b)(6) 2021 to treat degenerative mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the atrial septum and resistance was encountered while advancing the sgc across the septum.Tenting was noted but was felt to be normal.As the physician continued to push and advance the sgc, the sgc jumped impacting the lateral left atrial wall causing pericardial bleeding and cardiac tamponade.The mitraclip procedure was aborted with no insertion or implantation of mitraclips and no reduction in mr.The patient underwent surgical intervention for pericardiocentesis and repair of atrial perforation.Despite intervention, following surgery the patient died on (b)(6) 2021.In the physician¿s opinion, the jumping of the sgc and subsequent impact to the atrial wall contributed to the patient¿s death.A clinically significant delay was reported.No additional information was provided.
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Event Description
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Subsequent to the initially filed report, additional information was received.It was reported that the patient had challenging anatomy, specifically a floppy septum, that caused the resistance when advancing the steerable guide catheter (sgc) across the septum.The septum kept on pushing back on the sgc.The physician advanced the sgc against the resistance, and once the sgc was through the septum, there was a release of the tension from the septum, and the sgc went straight to and impacted the left atrial wall.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the unintended movement of the steerable guide catheter (sgc).The reported pericardial effusion, cardiac tamponade and subsequent death appear to be due to the reported perforation and the perforation appears to be relate to the unintended movement of the sgc.Pericardial effusion, cardiac tamponade, perforation and death are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported delay to treatment/therapy and surgical intervention were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.H6: medical device problem code 2524 was removed.
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Search Alerts/Recalls
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