Micropuncture G47947Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002479470), received between Apr 23, 2018 and Oct 19, 2020 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2020Unraveled Material; Unraveled Material

  AS REPORTED, DURING A PRE-FONTAN CARDIAC CATHETERIZATION THE WIRE GUIDE OF A MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET UNRAVELED. ACCESS WAS GAINED FROM THE RIGHT INTERNAL JUGULAR VEIN WITH THE SUPPLIED NEEDLE WITH GOOD BACKFLOW FROM THE VESSEL AND THE 0.018 WIRE WAS SMOOTHLY INTRODUCED. AFTER REACHING THE "EXPECTED DEPTH" THE USER ATTEMPTED TO WITHDRAW THE NEEDLE TO USE THE WIRE TO SELDINGER THE DILATOR. THE USER NOTED UNUSUAL RESISTANCE WHEN TRYING TO REMOVE THE NEEDLE AND THUS TRIED TO GENTLY PULL ON WIRE AND FOUND THAT IT STARTED TO UNRAVEL. THEY THEN SLOWLY PULLED BOTH THE WIRE AND NEEDLE OUT, BUT FOUND THAT THE THIN UNRAVELED WIRE WAS STILL IN THE VESSEL, WHICH GOT LONGER AS IT WAS REMOVED. THE ENTIRETY OF THE WIRE WAS REMOVED, DESPITE THE UNRAVELING. A HEMATOMA HAD FORMED AFTER THIS AND MADE THE NEXT PUNCTURE MORE CHALLENGING. THIS RESULTED IN THE NEED TO ACCESS THROUGH THE NECK AT A CRITICAL VESSEL AND WAS ULTIMATELY SUCCESSFUL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10698261 ↗
• InjuryApr 23, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY OF THE PULMONARY VALVE, THE MICROPUNCTURE TRANSITIONLESS PEDIATRIC ACCESS SET SHEATH WAS FOUND TO BE SPLIT INTO TWO PIECES. THIS EVENT OCCURRED AT SOME POINT DURING CANNULATION OF THE FEMORAL VEIN AND WAS DISCOVERED WHEN THE SHEATH WAS REMOVED. ONLY THE PROXIMAL PORTION WAS EXTRICATED OVER ANOTHER MANUFACTURER'S WIRE. THE DISTAL PORTION OF THE SHEATH WAS SEEN LODGED IN THE FEMORAL VEIN. THE GROIN AREA HAD SCARRING FROM A PREVIOUS CUT DOWN PROCEDURE BUT REPORTEDLY, THIS DID NOT MAKE THE INSERTION OF THE SHEATH DIFFICULT. THE COMPLAINANT POSTULATED THE SHEATH MUST HAVE SPLIT WHILE IN THE PATIENT; THEREFORE, IT COULD NOT HAVE BEEN CUT SINCE THE WIRE WAS WHOLLY INTACT UPON REMOVAL. THE COMPLAINANT REPORTED, THE SEPARATED PORTION OF THE SHEATH WAS SURGICALLY REMOVED AND THE PATIENT IS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 7451365 ↗