AccuStick™ II M001207030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729157601), received between Jul 16, 2019 and Aug 30, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE METAL RING MARKER DISLODGED AND WAS LEFT INSIDE THE PATIENT. A .038 ACCUSTICK II SYSTEM WAS SELECTED FOR USE FOR A PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT TO TREAT HYDRONEPHROSIS. A PERCUTANEOUS STICK WAS PERFORMED FROM THE SKIN TO THE KIDNEY. THE ACCUSTICK SET SHEATH WAS THEN ATTEMPTED TO BE REMOVED. HOWEVER, THE METAL RING MARKER OF THE TIP OF THE SHEATH BECAME DISLODGED AND SEPARATED SOMEWHERE IN THE SOFT TISSUES DEEP IN THE ABDOMINAL WALL. IT WAS DETERMINED THAT ADVANCING A NEPHROSTOMY TUBE OVER THE WIRE WOULD PUSH THE TINY METALLIC RING INTO THE KIDNEY AS THE RING WAS OBVIOUSLY AROUND THE WIRE SINCE IT BECAME DISLODGED WHILE REMOVING THE CATHETER OVER THE WIRE. THE PHYSICIAN DECIDED TO REMOVE THE ACCESS AND LEAVE THE METAL RING BEHIND AND OBTAIN A SECOND ACCESS POINT. IT WAS THEN DETERMINED TO LEAVE THE METAL RING INSTEAD OF RETRIEVING IT AS IT MIGHT CAUSE THE PATIENT MORE HARM AND PAIN. THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD OR DEVICE. THE PATIENT FELT DISCOMFORT/PAIN BUT WAS FULLY RECOVERED.

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 15322349 ↗
• MalfunctionMar 10, 2022Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON 17FEB2022. IT WAS REPORTED THAT THE INTRODUCER WIRE GOT UNRAVELED. THE TARGET LESION WAS LOCATED IN THE KIDNEY. A .038 ACCUSTICK II SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE INTRODUCER WIRE WAS CAUGHT ON THE INTRODUCER AND GOT UNRAVELED IN THE PROCESS OF GETTING OUT OF THE INTRODUCER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTRODUCER SHEATH AND SHEATH DILATOR WERE OBSERVED TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726922 ↗
• InjuryJul 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP BROKE OFF AND REMAINS IN THE PATIENT. AN ACCUSTICK II WAS SELECTED FOR A PERCUTANEOUS TRANSHEPATIC CHOLANGIODRAINAGE (PTCD) PROCEDURE. A SUCCESSFUL PUNCTURE OF THE BILE DUCT WAS MADE. THE GUIDEWIRE WAS INSERTED WITHOUT COMPLICATIONS INTO THE BILE DUCTS. WHILE ATTEMPTING TO INSERT THE DILATOR, THE 0.018 IN (0.47 MM) STAINLESS STEEL GUIDEWIRE WITH A 7.5 CM FLOPPY TIP BROKE OFF, WITHOUT GREATER FORCE, AT THE LEVEL OF THE RIBS. A PIECE OF THE WIRE, APPROXIMATELY 10 CM LONG, REMAINS IN THE LIVER. AN ATTEMPT WAS MADE TO RETRIEVE THE WIRE USING FORCEPS, BUT THIS WAS UNSUCCESSFUL. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS OR SYMPTOMS AS A RESULT. THE PROCEDURE WAS COMPLETED WITH A NEW ACCUSTICK.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8795069 ↗