Royal Flush G13771Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002137714), received between Nov 3, 2016 and Nov 3, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2016Material Separation; Material Separation

  IT WAS REPORTED DURING AN ANGIOPLASTY THE PHYSICIAN WAS PULLING THE PIGTAIL CATHETER WITH FORCE UP AND OVER THE BIFURCATION AREA AND THOUGHT THE CATHETER WAS CAUGHT ON SOLID PLAQUE AND NICKED THE CATHETER. THE FORCE REPORTEDLY CAUSED THE CATHETER TO KEEP SEPARATING IN THE MIDDLE SECTION OF THE CATHETER. THE PHYSICIAN WAS ABLE TO PUT A SNARE OVER THE WIRE AND SNARE THE PIECE OF CATHETER OUT OF THE PATIENTS ANATOMY. THE PHYSICIAN REPORTEDLY BELIEVED THE SEPARATION WAS DUE TO "EXCESSIVE CALCIUM." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6075684 ↗