R2P SLENGUIDE WG-S7ST1L23ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987892046636), received between Sep 27, 2018 and Sep 27, 2018 — classified as 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 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.

• MalfunctionSep 27, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE SLENGUIDE EXPERIENCED RESISTANCE (WHILE TRYING TO REMOVE THE WIRE) WHILE TRACKING OVER THE AMPLATZ SUPER STIFF WIRE. AFTER THE SLENGUIDE WAS REMOVED FROM THE SHEATH AND PLACED ON THE TABLE, A HOLE WAS NOTICED A COUPLE CM'S BELOW THE HUB. SINCE IT WAS THE ONLY ONE AVAILABLE, IT WAS REINTRODUCED OVER THE WIRE TO CONTINUE THE PROCEDURE. WHILE ATTEMPTING TO REMOVE IT FROM THE WIRE, IT BROKE APART WHERE IT WAS ORIGINALLY COMPROMISED. THE PATIENT CONDITION IS STABLE. THE PROCEDURE OUTCOME WAS REPORTED TO BE SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/17/2018. THE PROCEDURE BEING PERFORMED WAS A SMA ANGIOPLASTY AND STENTING. NO PIECES REMAINED INSIDE THE PATIENT, IT WAS NOT BEING USED WHILE BEING REMOVED OVER THE WIRE. ADDITIONAL INFORMATION WAS RECEIVED ON 9/19/2018. RESISTANCE WAS EXPERIENCED WHEN TRYING TO REMOVE OVER THE WIRE. WHEN THE SLENGUIDE BROKE APART, THE BROKEN SEGMENT WAS LOCATED OUTSIDE OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7914885 ↗