IDC™ M0033612020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729158684), received between Nov 13, 2019 and Nov 22, 2022 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• MalfunctionNov 22, 2022Contamination; Material Integrity Problem; Packaging Problem; Contamination; Material Integrity Problem; Packaging Problem

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. A 2MMX2CM IDC-18 SOFT COIL WAS SELECTED FOR USE. WHEN THE DEVICE WAS RECEIVED IN THE HEALTH CARE FACILITY FROM SHIPPING, IT WAS OBSERVED THAT THE PACKAGE WAS SMASHED IN THE CENTER OF THE HOOP. IT WAS NOTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THE OUTER PACKAGE WAS NOT DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847057 ↗
• DeathNov 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH A DISSECTION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT WAS BEING TREATED WITH A 2MMX2CM IDC COIL. THE COIL WAS BEING DELIVERED THROUGH A RENEGADE CATHETER. THE CATHETER WAS REPOSITIONED AND THE COIL DISLODGED INSIDE THE LAD. A SNARE WAS USED TO RETRIEVE THE DISLODGED COIL. DURING THE SNARING OF THE COIL, THE PATIENT BECAME UNSTABLE. THE PHYSICIAN CONTINUED COILING THE PATIENT WITH 3 ADDITIONAL IDC COILS THAT WERE SUCCESSFULLY IMPLANTED IN THE SEPTAL. A SYNERGY STENT WAS THEN PLACED INTO THE LAD A FEW MINUTES AFTER THE EMBOLIZATION PROCESS. THE PATIENT CODED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND ECHMO/ IMPELLA WERE USED. PATIENT DEATH OCCURRED. NO AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9318250 ↗