Adelante Sigma ASG07023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885672100954), received between Dec 31, 2018 and Dec 31, 2018 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2018Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING PCI PROCEDURE THERE WAS A NECESSITY FOR EXCHANGE FROM RADIAL TO FEMORAL ACCESS FOR THE GUIDING CATHETER SIZE 7FR COMPATIBILITY. AFTER INSERTING ON THE RIGHT SIDE THE INTRODUCER WITH 0.035" GUIDE WIRE, PHYSICIAN IS NOT ABLE TO GUIDE WITH MEDTRONIC LAUNCHER. CATHETER WAS TOUCHING THE TIP OF ADELANTE INTRODUCER AND EVEN USING A FORCE IT WAS IMPOSSIBLE TO GUIDE THE CATHETER THROUGH INTRODUCER TOWARDS AORTA. PHYSICIAN DECIDED TO CHANGE INTRODUCER INTO NEW MODEL 7FR ADELAMNTE SIGMA AS PREVIOUS BROKEN DURING INSERTION INTO PATIENT BODY. SAME SITUATION APPEARED WITH NEW INTRODUCE. WITH OTHER BRAND OF INTRODUCER CATHETER IS NOT ABLE TO CROSS THE TIP OF INTRODUCER EVEN IF USING A LOT OF FORCE AND MOVING PROXIMALLY AND DISTALLY. CONTINUATION OF TREATMENT IS NOT POSSIBLE AND PHYSICIAN RESCHEDULE THE SURGERY. WE ARE AWAITING INFORMATION ABOUT OTHER ADELANTE SIGMA 7F INTRODUCER. ONCE THE INFORMATION IS AVAILABLE WE WILL FILE SECOND MEDWATCH. NO ADDITIONAL INFORMATION IS AVAILABLE AND NO OTHER ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8206408 ↗