Super Sheath R/O (15-961B) BT50Z11PPWX38Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04543527181792), received between Jan 2, 2019 and Dec 5, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Difficult to Remove; Device-Device Incompatibility; Difficult to Remove; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SHEATH WAS DIFFICULT TO REMOVE. A 5FR INTRODUCER SHEATH WAS SELECTED FOR USE IN A TRANS-ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE. VASCULAR ACCESS WAS OBTAINED VIA A PUNCTURE OF THE RIGHT COMMON FEMORAL ARTERY (CFA). THE INTRODUCER SHEATH WAS ADVANCED INTO THE ARTERY OVER A STANDARD 0.035 GUIDEWIRE. A NON-BSC DIAGNOSTIC CATHETER WAS ADVANCED OVER THE GUIDEWIRE AND TORQUED 360 DEGREES. AT THIS POINT IT WAS OBSERVED THAT THE CATHETER COULD NOT BE RETRACTED, AND A GUIDEWIRE COULD NOT PASS THROUGH IT. A 0.018 NON-BSC GUIDEWIRE WAS ATTEMPTED FOR USE, BUT WAS UNSUCCESSFUL. THE CATHETER WAS MANAGED TO BE REMOVED WITH DIFFICULTY, AND A NEW .035 NON-BSC GUIDEWIRE WAS ADVANCED INTO THE AORTA. IT WAS THEN OBSERVED THAT THE CATHETER WAS COMPLETELY TWISTED ON ITSELF. THE SHEATH WAS THEN REMOVED, HOWEVER, IT WAS CRUMPLED AND DIFFICULT TO REMOVE. A NEW 5FR INTRODUCER SHEATH WAS SELECTED FOR USE. THERE WAS DIFFICULTY ADVANCING THE SHEATH INTO THE VESSEL. THE SHEATH WAS OBSERVED TO HAVE COILED UP UNDER THE SKIN WHICH RESULTED IN A HEMATOMA. A NEW 5FR SHEATH WAS SELECTED FOR USE. THE PROCEDURE WAS THEN ABLE TO BE COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO FURTHER PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268060 ↗
• MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562235 ↗
• MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8562176 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT THE DISTAL END OF THE SHEATH WAS DETACHED. THE TARGET LESION WAS LOCATED AT SUPERFACIAL FEMORAL ARTERY. A 5FR X 11CM SUPER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NON BSC CLOSURE DEVICE. AFTER WHICH, A NON BSC WIRE WAS INSERTED AND THE SHEATH WAS REMOVED OVER THE WIRE. HOWEVER, IT WAS NOTED THAT THE DISTAL END OF THE SHEATH HAD SEPARATED. THE LEG WAS CHECKED AND IMAGED AND IT WAS NOTED THAT THE DISTAL SHEATH TIP MARK ON THE SHEATH HAD BROKEN OFF IN THE SFA AND TRAVELLED DOWN TO THE POPLITEAL ARTERY. THE PHYSICIAN THEN USED A MACH 1 GUIDE CATHETER TO ASPIRATE THE DISTAL TIP OF THE SHEATH OUT IN THE BODY AND IT WAS THEN LODGED IN THE SOFT TISSUE TRACK. FINALLY, THE PHYSICIAN RETRIEVED THE DISTAL END OF THE SHEATH OUT OF THE SOFT TISSUE TRACK OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO WIRE LEFT IN THE SHEATH. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Code Available

  MAUDE report 8208813 ↗