TSX™ 00884450265604Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450265604), received between Apr 29, 2020 and Jun 22, 2022 — classified as 4 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A TRANSSEPTAL PUNCTURE WITH THE TSX FIXED CURVE SHEATH THE PATIENT DEVELOPED AN AIR EMBOLISM WITH NO KNOWN DEVICE PROBLEM OCCURRING. THE PROCEDURE WAS CANCELED AND RESCHEDULED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Air Embolism

  MAUDE report 14782469 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE [LAAC] PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED ACCESS TO THE PATIENTS LEFT ATRIUM VIA TRANSSEPTAL PUNCTURE. A CLOSURE DEVICE WAS INTRODUCED INTO THE LEFT ATRIUM -A COUPLE OF TIMES- NEEDING RECAPTURE DUE TO A 5 MM GAP THAT WAS APPRECIATED. A 33 MM CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED WITHIN THE POSTERIOR LOBE WHEN A PERICARDIAL EFFUSION WAS NOTED. A FULL RECAPTURE OF THE CLOSURE DEVICE WAS COMPLETED. THE PATIENT WAS IN STABLE CONDITION, SO A NEW 33 MM CLOSURE DEVICE WAS IMPLANTED IN THE UPPER LOBE. AFTER FIRST RELEASE OF THE SECOND DEVICE, GOOD POSITIONING WAS OBSERVED. EVENTUALLY THE PATIENT'S VITAL SIGNS CHANGED INDICATING THAT CARDIAC MASSAGE AND PERICARDIOCENTESIS WAS NECESSARY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO SURGERY.

  Patient problems: Patient Problem/Medical Problem; Pericardial Effusion

  MAUDE report 10141387 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A LEFT ATRIAL APPENDAGE CLOSURE [LAAC] PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN HAD SUCCESSFULLY ACQUIRED ACCESS TO THE PATIENTS LEFT ATRIUM VIA TRANSSEPTAL PUNCTURE. A CLOSURE DEVICE WAS INTRODUCED INTO THE LEFT ATRIUM -A COUPLE OF TIMES- NEEDING RECAPTURE DUE TO A 5 MM GAP THAT WAS APPRECIATED. A 33 MM CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED WITHIN THE POSTERIOR LOBE WHEN A PERICARDIAL EFFUSION WAS NOTED. A FULL RECAPTURE OF THE CLOSURE DEVICE WAS COMPLETED. THE PATIENT WAS IN STABLE CONDITION, SO A NEW 33 MM CLOSURE DEVICE WAS IMPLANTED IN THE UPPER LOBE. AFTER FIRST RELEASE OF THE SECOND DEVICE, GOOD POSITIONING WAS OBSERVED. EVENTUALLY THE PATIENT'S VITAL SIGNS CHANGED INDICATING THAT CARDIAC MASSAGE AND PERICARDIOCENTESIS WAS NECESSARY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO SURGERY.

  Patient problems: Patient Problem/Medical Problem; Pericardial Effusion

  MAUDE report 10141386 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A TRANSSEPTAL PUNCTURE TO COMPLETE AN A-FIB ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PHYSICIAN HAD ACQUIRED ACCESS VIA THE PATIENT'S FEMORAL VENOUS SYSTEM WITH A LARGE BORE SHEATH AND HAD NEGOTIATED THE ABDOMINAL AORTA WITH A GUIDEWIRE AND GUIDE CATHETER. THE TRANSSEPTAL NEEDLE WAS THEN INSERTED AND POSITIONED TO ALIGN WITH THE PATIENT'S FOSSA OVALIS FOR ACCESS THROUGH AND INTO LEFT ATRIUM WITH A CORONARY SINUS CATHETER. AFTER ACQUIRING TRANSSEPTAL ACCESS [LA] THE PATIENT DEMONSTRATED SIGNS AND SYMPTOMS OF CARDIAC DECOMPENSATION, PAIN IN THE LOWER STOMACH, ASCITES, AND PLEURAL EFFUSION WAS NOTED. POST PROCEDURE THE PATIENT COMPLAINED OF EXERTIONAL DYSPNEA [DIFFICULT OR LABORED BREATHING] AND VERTIGO, [DIZZINESS]. THE PATIENT WAS ALSO ADMINISTERED ANTIBIOTICS POST PROCEDURE. THE ACCOUNT ALLEGES THAT THE PATIENT SUFFERED FROM PNEUMONIA. IT IS UNKNOWN IF THE TRANSSEPTAL ACCESS NEEDLE WAS EXCLUSIVELY RESPONSIBLE FOR THE PLEURAL EFFUSION AND/OR OTHER SYMPTOMS DURING THIS PROCEDURE EVENT.

  Patient problems: Atrial Fibrillation; Bronchopneumonia; Pleural Effusion

  MAUDE report 10012236 ↗