TSX™ Transseptal Needle 00884450451717Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450451717), received between Nov 30, 2021 and Dec 12, 2023 — classified as 1 death, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT POST-TRANSEPTAL PUNCTURE, DURING AN ABLATION PROCEDURE FOR ATRIAL TACHYCARDIA, PERICARDIAL EFFUSION WAS NOTED, AND CARDIAC PERFORATION COULD NOT BE RULED OUT. THE PHYSICIAN ADVANCED AN ICE CATHETER AND ORDERED AN ECHO STUDY TO CONFIRM THE EFFUSION WAS DEVELOPING. PERICARDIAL PERFORATION WAS RULED OUT AT THIS TIME. AN EMERGENT PERICARDIOCENTESIS [PC] WAS PERFORMED. DURING THE PC, THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA [VT] ARRHYTHMIA SO THE PATIENT WAS SUCCESSFULLY DEFIBRILLATED TO NORMAL SINUS RHYTHM. POST PC DRAINAGE PLACEMENT, 700CC OF FLUID WAS SUCCESSFULLY REMOVED FROM THE PATIENT PERICARDIAL SPACE. THE PATIENT WAS RETURNED TO THE UNIT FOR OBSERVATION IN STABLE CONDITION.

  Patient problems: Arrhythmia; Pericardial Effusion

  MAUDE report 18313049 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING THE EARLY STAGES OF THE PROCEDURE (VASCULAR ACCESS) A TRANS-ESOPHAGEAL-ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND A SMALL PERICARDIAL EFFUSION NOTED WHILST THE PATIENT WAS IN A HYPERTENSIVE STATE. THE DECISION WAS MADE BY THE TREATING CLINICIAN TO CONTINUE THE CASE USING THE TSX FIXED SHEATH AND TSX NEEDLE, ON WHICH THE OPERATOR WAS ALSO PROPERLY TRAINED. THE DEVICES WERE INSERTED IN ORDER TO PROBE THE INTRA-ATRIAL SEPTUM FOR A SUFFICIENT SPOT TO REACH THE LEFT ATRIUM. DURING THE PROBING, AN INCREASE OF THE FORMERLY MENTIONED PERICARDIAL EFFUSION WAS DETECTED IN THE TEE AND BEFORE THE PASSAGE OF THE SEPTUM OCCURRED A PERICARDIAL PUNCTURE WAS DEEMED NECESSARY BY THE CLINICIAN IN ORDER TO MITIGATE THE PROBLEM AND RETURN TO A STABLE STATE FOR THE PATIENT. AS PER THE IFU OF THE SYSTEM, THE CLINICIAN AS ADVISED THAT AN ELEVATED ACT <300SEC. HAD TO BE MAINTAINED DURING THE ENTIRE LEFT ATRIAL DWELL-TIME OF THE CATHETER AND THAT FAILURE TO DO SO COULD POTENTIALLY HAVE A NEGATIVE EFFECT ON THE PERICARDIAL TAMPONADE. THE CLINICIAN DECIDED TO MOVE FORWARD AND PERFORM THE TRANSSEPTAL PUNCTURE UNDER CONSTANT TEE SUPERVISION AND EXCHANGING THE TSX SHEATH FOR THE POL

  Patient problems: Cardiac Tamponade

  MAUDE report 17736019 ↗
• DeathNov 30, 2021Adverse 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 THE OPERATING PHYSICIAN EXPERIENCED COMPLICATIONS WITH THE TRANSSEPTAL NEEDLE KIT AND STEERABLE SHEATH. IT IS ALLEGED THAT "DEVICE ISSUES" MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT COMPLICATIONS DURING THE PROCEDURE. THE ACCOUNT ALLEGES THAT "THE ATTENDING PHYSICIAN NEEDED TO REPOSITION THE STEERABLE SHEATH REPEATEDLY THROUGHOUT THE PROCEDURE". THE PATIENT EXPERIENCED A POSSIBLE "LEAK" [PERICARDIAL EFFUSION] THAT MAY HAVE LED TO POSSIBLE CARDIAC TAMPONADE ON THE LEFT ATRIAL APPENDAGE SIDE. A CODE WAS ACTIVATED, AND HOSPITAL PROTOCOLS WERE INITIATED IN ATTEMPTS TO STABILIZE THE PATIENT. THE LAA CLOSURE DEVICE WAS SUCCESSFULLY DEPLOYED DURING THIS PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2021. NO ADDITIONAL INFORMATION ABOUT THIS EVENT HAS BEEN PROVIDED TO MERIT MEDICAL BY THE ACCOUNT. A GOOD FAITH EFFORT OF 3 OR MORE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN SUCCESSFULLY COMPLETED BY THE MANUFACTURER IN A TIMELY MANNER.

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade

  MAUDE report 12902241 ↗