CPS AIM™ DS2N026-59Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067005717), received between Oct 10, 2019 and Dec 11, 2024 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INITIAL IMPLANT PROCEDURE, WHICH ADVANCING THE CATHETER, THE PATIENT SUSTAINED A TEAR IN THE CORONARY SINUS VEIN. CONTRACT WAS INJECTED AND THE CATHETER WAS VISUALIZED OUT OF THE VEIN ON FLUOROSCOPY. AN ECHOCARDIOGRAM WAS PERFORMED AND DID NOT REVEAL ANY ADDITIONAL SYMPTOMS. THE SURGERY WAS ENDED WITHOUT IMPLANTING SYSTEM. THE PATIENT WAS STABLE AND NO ADDITION INTERVENTION WAS REQUIRED TO ADDRESS THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 20903091 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT PRESENTED DURING PROCEDURE. DURING PROCEDURE, THE INNER CATHETER ADVANCEMENT WITHIN CORONARY SINUS(CS) LED TO VASCULAR DISSECTION. THE CASE WAS ABANDONED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 17646911 ↗
• MalfunctionJul 26, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS EXTREMELY TIGHT, AND THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE LEAD. BOTH CATHETERS WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107816 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, A DISSECTION OF THE CORONARY SINUS WAS OBSERVED AND WAS CONFIRMED WITH FLUOROSCOPY. IT WAS SUSPECTED THE DISSECTION WAS DUE TO THE CPS CATHETER. NO INTERVENTION WAS REQUIRED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 12196084 ↗
• 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, 2017865-2019-14945. 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 9177009 ↗