CPS Direct™ DS2C021Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05415067004208), received between Mar 7, 2019 and Nov 25, 2024 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL IMPLANT PROCEDURE, THE PATIENT DEVELOPED A PERFORATION OF THE EPICARDIUM WHILE MANEUVERING THE CATHETER. LATER DURING THE PROCEDURE, THE PERFORATION RESULTED IN A PERICARDIAL EFFUSION WHICH RESULTED IN THE PATIENT LOSING CONSCIOUSNESS AND CEASING BREATHING. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED UNTIL THE PATIENT STABILIZED. THE IMPLANT PROCEDURE WAS ABANDONED. NO ALLEGATION OF MALFUNCTION WAS MADE AGAINST THE CATHETER. LEAD IMPLANTATION IS STILL BEING CONSIDERED. HOWEVER, NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Pericardial Effusion; Syncope/Fainting

  MAUDE report 20775986 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND BRADYCARDIA FOLLOWING A VASCULAR DISSECTION DUE TO USE OF THE CATHETER. A PERICARDIAL EFFUSION WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Arrhythmia; Cardiac Perforation; Pericardial Effusion; Vascular Dissection

  MAUDE report 20158180 ↗
• InjuryJan 27, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING INITIAL IMPLANT, WHILE THE LEAD WAS BEING POSITIONED IN THE RIGHT ATRIUM (RA) A DISSECTION WAS NOTED DUE TO INCORRECT INSERTION TECHNIQUE USED BY THE PHYSICIAN. THE DISSECTION SPONTANEOUSLY RESOLVED AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 13366296 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2021. UPON EXAMINATION, IT WAS NOTED THAT THE CATHETER HAD DISSECTED THE CORONARY SINUS. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 12834167 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, DISSECTION OF THE CORONARY SINUS BY THE CATHETER OCCURRED. THE PROCEDURE WAS ENDED AND NO LV LEAD WAS IMPLANTED. NO INTERVENTION WAS PERFORMED TO TREAT THE DISSECTION; THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: Vascular Dissection

  MAUDE report 11605630 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER PUNCTURED A PATIENT'S HEART DURING A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR UPGRADE PROCEDURE. THE PUNCTURE WAS DISCOVERED BY A FLUOROSCOPY. THE PATIENT WAS HEMODYNAMICALLY STABLE. CATHETER WAS REMOVED SAFELY. THE UPGRADE PROCEDURE WAS ABANDONED. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 10731292 ↗
• DeathOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2019-14938, 2017865-2019-14940, 2017865-2019-14942, 2017865-2019-14943, 2017865-2019-14944, 2017865-2019-14945. IT WAS REPORTED THAT THE PATIENT EXPIRED DURING AN IMPLANT PROCEDURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO RESPIRATORY ISSUES DURING THE PROCEDURE.

  Patient problems: Death

  MAUDE report 9177016 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04385. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2019-04386. IT WAS REPORTED THAT DURING AN INITIAL IMPLANT PROCEDURE, AFTER IMPLANTATION OF A RIGHT VENTRICULAR PACING LEAD, THE PHYSICIAN ATTEMPTED TO IMPLANT A QUADRIPOLAR PASSIVE LEAD IN THE LEFT VENTRICLE. PHYSICIAN COMPLAINED OF TIGHTNESS OF SUB-SELECTOR AROUND THE LV LEAD. THE LEAD COULDN¿T BE ADVANCED ALL THE WAY THROUGH THE SUB SELECTOR OF THE INNER CATHETER. ANOTHER INNER CATHETER WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, THE DISTAL CORONARY SINUS (CS) WAS PERFORATED/ DISSECTED WHILE USING THE CPS UNIVERSAL DELIVERY SYSTEM OUTER AND INNER CATHETERS. THE PERFORATION RESULTED IN SIGNIFICANTLY LOWERED BLOOD PRESSURE, CARDIAC TAMPONADE, AND LOSS OF PULSE READINGS. THE PATIENT LOST A SIGNIFICANT AMOUNT OF BLOOD. THE PATIENT WAS ADMINISTERED CHEST COMPRESSIONS, RECEIVED MULTIPLE EXTERNAL DEFIBRILLATOR SHOCKS FOR SPONTANEOUS VF, AND WAS ADMINISTERED AN INTRATHORACIC NEEDLE AND CHEST TUBE TO EVACUATE BLOOD FROM THE PERICARDIUM. THE IMPLANT OF THE LEFT VENTRICULAR LEAD WAS DISCONTINUED AFTER THE TAMPONADE OCCURRED. UPON HEMODYNAMIC NORMALIZATION OF THE PATIENT, A RIGHT ATRIA

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Vascular Dissection

  MAUDE report 8667955 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, THERE WAS A DISSECTION NOTED ON THE CORONARY SINUS (CS) WITH ECHOCARDIOGRAM IMAGING DUE TO THE INTRODUCER TOOL. THERE WAS NO PERICARDIAL EFFUSION OR OTHER ADVERSE CONSEQUENCE AS A RESULT OF EVENT. THE PROCEDURE WAS POSTPONED TO A LATER DATE AND THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 8399780 ↗