CPS AIM™ DS2N028-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067005755), received between Oct 2, 2018 and Jun 4, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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: 2938836-2019-04387. 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 8667908 ↗
• MalfunctionOct 2, 2018Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE INNER SHEATH OF THE SLITTABLE INNER CATHETER BROKE INTO TWO PIECES. BOTH PIECES WERE REMOVED. THERE WERE NO RELATED OR ANCILLARY ISSUES WITH THE LEAD OR OTHERWISE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7928478 ↗