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BRK-1™ G407215Recalls & reported problems

St. Jude Medical Cardiovascular Division · Transseptal Needle · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734207225), received between Sep 27, 2018 and Jun 27, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Insert2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Consequences Or Impact To Patient2
  • Cardiac Perforation1

Recent adverse event reports

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

  • InjuryJun 27, 2020Difficult to Insert; Difficult to Insert

    RELATED MANUFACTURER REFERENCE: 3005334138-2020-00235, 3005334138-2020-00261, 3008452825-2020-00329. DURING A PROCEDURE, RESISTANCE WAS NOTED WHILE TRYING TO ADVANCE THE BRK NEEDLE. FORCE WAS NEEDED TO ADVANCE THE DEVICE. THE SHEATH AND NEEDLE WERE REPLACED, AND AGAIN THE ISSUE WAS NOTED. THE DEVICES WERE REPLACED A THIRD TIME AND RESOLUTION WAS FOUND TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL ACCESS SITE WAS REQUIRED, HOWEVER A CLINICALLY SIGNIFICANT DELAY OF 20-30 MINUTES WAS NOTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10204362 ↗
  • InjuryJun 27, 2020Difficult to Insert; Difficult to Insert

    RELATED MANUFACTURER REFERENCE: 3005334138-2020-00235, 3005334138-2020-00261, 3008452825-2020-00330. DURING A PROCEDURE, RESISTANCE WAS NOTED WHILE TRYING TO ADVANCE THE BRK NEEDLE. FORCE WAS NEEDED TO ADVANCE THE DEVICE. THE SHEATH AND NEEDLE WERE REPLACED, AND AGAIN THE ISSUE WAS NOTED. THE DEVICES WERE REPLACED A THIRD TIME AND RESOLUTION WAS FOUND TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL ACCESS SITE WAS REQUIRED, HOWEVER A CLINICALLY SIGNIFICANT DELAY OF 20-30 MINUTES WAS NOTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10204361 ↗
  • InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURER REFERENCE: 3008452825-2018-00336. DURING A PULMONARY VEIN ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. DURING ABLATION ON THE LEFT POSTERIOR WALL, THE PATIENT BECAME HYPOTENSIVE AND AN EFFUSION WAS NOTED AND MONITORED USING ICE AND MEDICATION WAS ADMINISTERED. DURING ABLATION OF THE RIGHT SIDE OF THE PULMONARY VEINS, THE PATIENT STABILIZED AND THE PROCEDURE WAS COMPLETED. A PERICARDIOCENTESIS WAS PERFORMED, HOWEVER BLEEDING CONTINUED. THE HEMOGLOBIN LEVEL DROPPED FROM 8.0 TO BASELINE TO 5.0 DURING THE PERICARDIOCENTESIS AND THE PATIENT WAS THEN TRANSFERRED TO THE OR FOR A STERNAL THORACOTOMY AND BLOOD TRANSFUSION. SURGERY CONFIRMED A PERFORATION BETWEEN THE LEFT SUPERIOR VEIN AND APPENDAGE, WHICH WAS REPAIRED TO STABILIZE THE PATIENT. IT WAS INDICATED THE PERFORATION OCCURRED DURING TRANSSEPTAL WITH THE AGILIS. THE PHYSICIAN FELT THE DILATOR LENGTH CONTRIBUTED TO THE PERFORATION.

    Patient problems: Cardiac Perforation

    MAUDE report 7915942 ↗

Other Trocar devices

All Trocar devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.