Skater™ Introducer System 651506300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333004515), received between Oct 27, 2021 and Jun 1, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2024Dull, Blunt; Dull, Blunt

  THE REPORTER INDICATED THE INTRODUCER WITH THE THICK TIP WAS NOT ABLE TO PIERCE THE RENAL AND HEPATIC CAPSULES EASILY. DURING THE NEPHROSTOMY PROCEDURE, THE INTRODUCER HAD DIFFICULTY PERFORATING THE KIDNEY AND CAUSED RENAL BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19442137 ↗
• MalfunctionAug 17, 2023Break; Break

  THE 21G PUNCTURE NEEDLE IS VERTICALLY INSERTED INTO THE TARGET CATHETER, THE NEEDLE CORE IS WITHDRAWN, AND IOKESARTOL IS INJECTED. THE RIGHT HEPATIC DUCT IS SEEN TO DEVELOP AND EXPAND, THE PORTAL IS NARROW, AND THE GUIDE WIRE IS INSERTED INTO THE HUMAN BODY. IT IS DIFFICULT TO FIND THE CAVITY TO ENTER THE COMMON BILE DUCT. THE LEFT HEPATIC DUCT IS EXPLORED BY B-ULTRASOUND, AND 2% LIDOCAINE IS GIVEN TO LOCAL ANESTHESIA TO THE LIVER SURFACE. IT IS PROPOSED TO CONDUCT PTCD, AND THE 21G PUNCTURE NEEDLE IS INSERTED INTO THE TARGET CATHETER, THE NEEDLE CORE IS WITHDRAWN, AND IOKESARTOL IS INJECTED. THE LEFT HEPATIC DUCT DEVELOPMENT AND EXPANSION ARE SEEN TO PUSH THE DILATOR ALONG THE GUIDE WIRE, IN VIVO OF PATIENTS WITH BROKEN AND DELAYED GUIDE WIRES

  Patient problems: Insufficient Information

  MAUDE report 17566467 ↗
• MalfunctionApr 6, 2023Material Fragmentation; Peeled/Delaminated; Material Fragmentation; Peeled/Delaminated

  DURING THE INSERTION OF THE DRAINAGE TUBE, THE GUIDE WIRE WAS STRIPPED AND LEFT IN THE PATIENT'S BODY, AND ADDITIONAL GUIDE WIRES WERE USED TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16690868 ↗
• MalfunctionOct 23, 2022Nonstandard Device

  GUIDEWIRE IN SKATER SET FRACTURED IN PATIENT WHEN DILATING SHEALTH WAS ADVANCE AND REMAINED IN PATIENT. UNABLE TO SNARE THE WIRE AT THE TIME. PATIENT UNDERWENT SUBSEQUENT UNSUCCESSFUL CT WIRE LOCALISATION AND SURGICAL CUT DOWN. WIRE WAS FINALLY REMOVED VIA URETEROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656412 ↗
• InjuryOct 27, 2021Break

  PATIENTS WITH CHOLANGIOCARCINOMA WERE TREATED WITH NASOBILIARY DRAINAGE. HEPATOBILIARY SURGERY DECIDED TO PERFORM PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) AGAIN IN OUR HOSPITAL, SO AS TO FURTHER IMPROVE THE EFFECT OF BILE DRAINAGE, CONTROL BILIARY INFECTION AND CREATE CONDITIONS FOR THE NEXT TREATMENT. ON (B)(6) 2021, THE PATIENT TOOK THE SUPINE POSITION IN THE OPERATING ROOM. THE FLUOROSCOPY SHOWED THAT THE POSITION OF THE NASOBILIARY DRAINAGE TUBE WAS GOOD, THE CONTRAST MEDIUM INJECTED SHOWED THAT THE INTRAHEPATIC BILE DUCT WAS WELL DEVELOPED, SOME BRANCHES OF THE LEFT HEPATIC DUCT WERE SLIGHTLY DILATED, AND THE NASOBILIARY DRAINAGE WAS UNOBSTRUCTED. ROUTINE DISINFECTION AND TOWEL LAYING UNDER THE XIPHOID PROCESS, LOCAL INFILTRATION ANESTHESIA WITH 5ML OF 1% LIDOCAINE, PUNCTURE THE LEFT HEPATIC DUCT BRANCH UNDER THE PERSPECTIVE OF 21G MICRO PUNCTURE NEEDLE, AND AFTER FEEDING THE MICRO GUIDE WIRE, ABOUT 5CM OF THE HEAD END OF THE MICRO GUIDE WIRE WAS BROKEN, AND THE BROKEN PART RUSHED INTO THE RIGHT LOWER PULMONARY ARTERY WITH BLOOD FLOW THROUGH THE HEPATIC VEIN. THE LEFT HEPATIC DUCT BRANCH WAS RE PUNCTURED AND EXPANDED, AND SENT TO THE 8F MULTI HOLE PIGTAIL DRAINAGE TUB

  Patient problems: Insufficient Information

  MAUDE report 12705940 ↗