Rosch-Uchida G06929Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00827002069299), received between Sep 12, 2016 and Apr 24, 2026 — classified as 2 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 26, 2025Open, Classified

   Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

   Z-0995-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Unraveled Material

  IT WAS REPORTED THAT DIFFICULT ADVANCEMENT WAS EXPERIENCED WITH A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET. THE DEVICE WAS REQUIRED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT IN THE LIVER. DURING THE PROCEDURE, THE STIFFENING CANNULA AND 10 FRENCH BLACK CATHETER ASSEMBLY WAS DIFFICULT TO ADVANCE THROUGH THE FLEXOR SHEATH. IT WAS NOTED THAT THE FLEXOR SHEATH WAS FLUSHED WITH SALINE PRIOR TO ADVANCEMENT OF COMPONENTS. THE PATIENT DID NOT HAVE TORTUOUS OR CALCIFIED ANATOMY. A NEW SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. DURING EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE FLEXOR SHEATH HAD UNRAVELED, THUS PROMPTING THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983705 ↗
• MalfunctionApr 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT A 5 FRENCH BLUE STYLET CATHETER INCLUDED IN THE ROSCH UCHIDA TRANSJUGULAR LIVER ACCESS SET WAS DAMAGED. DURING ASSEMBLY OF THE SET FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, IT WAS NOTED THAT THE 5 FRENCH BLUE CATHETER WAS DAMAGED AND COULD NOT BE USED. THEREFORE, A NEW SAME DEVICE WAS USED TO CONTINUE THE PROCEDURE. A CUSTOMER PROVIDED PHOTOGRAPH REVEALS A TEAR OR SPLIT IN THE SHAFT OF THE BLUE CATHETER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896075 ↗
• MalfunctionMar 18, 2026Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630044 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT THE FLEXOR SHEATH FROM A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET WAS DIFFICULT TO ADVANCE. DURING THE UNSPECIFIED PROCEDURE FOR A 69-YEAR-OLD FEMALE PATIENT, THE OPERATOR SUDDENLY NOTICED A SIGNIFICANT INCREASE IN RESISTANCE WHILE PUSHING THE FLEXOR SHEATH, AND THE SHEATH COULD NOT BE SMOOTHLY ADVANCED; THIS WAS ACCOMPANIED BY A SLIGHT AND CLEAR FRACTURE LIKE SOUND. THEREFORE, THE OPERATOR IMMEDIATELY STOPPED ADVANCING THE SHEATH AND GENTLY AND QUICKLY REMOVED THE SHEATH COMPLETELY FROM THE SURGICAL AREA. SUBSEQUENTLY, THE SURGEON CONDUCTED A PRELIMINARY VISUAL INSPECTION OF THE WITHDRAWN SHEATH. NO INFORMATION REGARDING THE STATE OF THE FLEXOR SHEATH WAS PROVIDED AT THE TIME OF INITIAL REPORT. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE OF THE SAME CATALOG NUMBER. THE SUBSEQUENT PROCEDURE WENT SMOOTHLY WITH NO ABNORMAL SITUATIONS OCCURRING AGAIN. AFTER THE PROCEDURE, IMAGING WAS PERFORMED OF THE PATIENT'S SURGICAL AREA TO CONFIRM NO FOREIGN MATTER RESIDUES; THE PATIENT'S VITAL SIGNS WERE STABLE. THE RETURNED DEVICE WAS RETURNED AND EVALUATED 05FEB2026 REVEALING A BROKEN FLEXOR SHEATH, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370824 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT THE FLEXOR SHEATH FROM A RÖSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET SEPARATED. THE TRANSJUGULAR LIVER ACCESS SET WAS REQUIRED FOR A PATIENT UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE IN THE GASTROENTEROLOGY DEPARTMENT. HEPATIC ANGIOGRAPHY WAS USED TO SHOW THE POSITION OF THE PORTAL VEIN AND TO PUNCTURE THE JUGULAR VEIN. THE DEVICE WAS TO BE USED FOR PUNCTURE BETWEEN THE HEPATIC VEIN AND PORTAL VEIN. HOWEVER, AFTER OPENING THE PACKAGING OF THE SET, RESISTANCE BETWEEN THE FLEXOR SHEATH AND THE 10 FRENCH BLACK CATHETER/STIFFENING CANNULA COMBINATION WAS EXPERIENCED, RESULTING IN SEPARATION OF THE FLEXOR SHEATH NEAR THE HUB. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW LIVER ACCESS SET WITH THE SAME CATALOG NUMBER. THE SITUATION IMPROVED SLIGHTLY, AND THE PUNCTURE WAS SUCCESSFULLY PERFORMED. SUBSEQUENTLY, BALLOON DILATION AND STENT IMPLANTATION WERE PERFORMED. PROCEDURAL IMAGING CONFIRMED SMOOTH BLOOD REFLUX AND A DECREASE IN PORTAL VEIN PRESSURE TO THE IDEAL RANGE. PATIENT BANDAGED AND SAFELY RETURNED TO THE WARD. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221150 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT THE FLEXOR SHEATH FROM A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET SEPARATED. DURING THE PROCEDURE, THE SHEATH EXPERIENCED SIGNIFICANT RESISTANCE DURING ADVANCEMENT, AND A SLIGHT, CLEAR FRACTURE-LIKE SOUND WAS HEARD. THE SHEATH WAS GENTLY AND QUICKLY REMOVED FROM THE PATIENT AND THE SURGICAL AREA TO AVOID COMPLICATIONS. THE SURGICAL AREA CONDITION WAS EVALUATED, AND ANOTHER LIKE-DEVICE WAS OBTAINED AND WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A PROVIDED PHOTO SHOWS THE SHAFT OF THE FLEXOR SHEATH BROKE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176799 ↗
• MalfunctionDec 15, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE 10 FRENCH FLEXOR SHEATH INCLUDED IN THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET "DISCONNECTED FROM THE CONNECTION VALVE". A CUSTOMER PROVIDED PHOTO REVEALS UNRAVELING OF THE INNER COIL OF THE FLEXOR SHEATH. THIS ISSUE WAS SAID TO OCCUR UPON ATTEMPTED INSTALLATION OF THE SHEATH OVER A 260 CM COOK ROSEN WIRE GUIDE, LEADING TO DIFFICULT ADVANCEMENT OF THE SHEATH INTO THE PATIENT'S VESSEL. ANOTHER SET WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810793 ↗
• MalfunctionDec 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718524 ↗
• MalfunctionDec 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED IN ADDITIONAL INFORMATION RECEIVED 27JAN2026, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718307 ↗
• MalfunctionNov 12, 2025Break; Break

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533701 ↗
• MalfunctionOct 29, 2025Break; Break

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415898 ↗
• MalfunctionOct 21, 2025Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351739 ↗
• MalfunctionOct 21, 2025Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350238 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027034 ↗
• MalfunctionAug 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, "DUE TO ANGLE", THE NEEDLE FROM A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET" PERFORATED THE SHEATH DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE IN A 33-YEAR-OLD FEMALE PATIENT. IN ADDITIONAL INFORMATION RECEIVED 13AUG2025, IT WAS CLARIFIED THAT THE 14G STIFFENING CANNULA PERFORATED THE 5FR BLUE CATHETER. THUS, PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854783 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE TROCAR STYLET INCLUDED IN THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET BROKE DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE ON A 49-YEAR-OLD FEMALE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATIVE PUNCTURE PRODUCT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613674 ↗
• MalfunctionJul 21, 2025Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BLUE 5.0FR CATHETER INCLUDED IN THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET WAS PUNCTURED DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE FOR A 68-YEAR-OLD FEMALE PATIENT. THERE WAS DIFFICULTY INSERTING THE 14G STIFFENING CANNULA INTO THE 10F SHEATH, WHICH WAS USED TO POSITION THE SUPPORT CANNULA. THIS OCCURRED BECAUSE THE 10F INTRODUCER WAS NOT COMPATIBLE WITH THE STIFFENING CANNULA. THE 14G STIFFENING CANNULA, THE 0.038-INCH TROCAR STYLET, THE 5F BLUE CATHETER, AND THE 10F CATHETER, ALL WERE IMPACTED BY THE FAILURE. THERE WAS DIFFICULTY ADVANCING BOTH THE STIFFENING CANNULA AND THE 0.038-INCH TROCAR STYLET. SPECIFICALLY, THE STYLET COULD NOT PASS THROUGH THE 5F BLUE CATHETER AND, AFTER TWO ATTEMPTS, PUNCTURED IT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THAT THE VASCULAR SHEATH SURFACE WAS PUNCTURED DUE TO REPEATED INSERTIONS. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556593 ↗
• MalfunctionJul 1, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB OF THE SHEATH IN A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET SEPARATED. DURING A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) PROCEDURE FOR A 67-YEAR-OLD MALE PATIENT, THE HUB OF THE SHEATH BROKE UPON INSERTION/PUNCTURE OF THE SHEATH. THE USER RETRACTED THE DEVICE AND USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373097 ↗
• MalfunctionJun 4, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE METAL STIFFENING CANNULA AND BLACK CATHETER OF A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET ENCOUNTERED RESISTANCE WHEN BEING ADVANCED THROUGH THE FLEXOR SHEATH. THE 10 FR FLEXOR SHEATH WAS ROUTINELY WASHED AND PLACED IN THE PATIENT'S BODY. THE METAL STIFFENING CANNULA AND BLACK CATHETER WERE ASSEMBLED. UPON ENTERING THE SET THROUGH THE FLEXOR SHEATH, GREAT RESISTANCE WAS NOTED. THE DEVICE WAS NOT ABLE TO BE USED. A NEW LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN OF THE DEVICE FOR EVALUATION ON 19MAY2025, IT WAS NOTED THAT THE INNER LINER OF THE SHEATH SHOWED DELAMINATION; THUS, PROMPTING THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143084 ↗
• MalfunctionJun 3, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB OF THE FLEXOR SHEATH FROM A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET (RUPS) SEPARATED. THE DEVICE WAS REQUIRED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. DURING THE PROCEDURE, A 5F CATHETER WAS USED TO SUCCESSFULLY PUNCTURE THE RIGHT INTERNAL JUGULAR VEIN. FOLLOWING ACCESS, A HYDROPHILIC-COATED GUIDEWIRE WAS ADVANCED INTO THE VESSEL. THE RUPS WAS THEN PREPARED FOR EXCHANGE OVER THE WIRE. UPON ATTEMPTING TO ADVANCE THE RUPS ALONG THE GUIDEWIRE, IT WAS OBSERVED THAT THE WHITE HUB OF THE 10 FRENCH FLEXOR SHEATH HAD SEPARATED. A NEW RUPS SET WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE TAPERED GRAY DILATOR WAS INSIDE THE SHEATH AT THE TIME OF INITIAL INSERTION. THE PATIENT DID NOT HAVE ANY TORTUOUS ANATOMY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134536 ↗
• MalfunctionMay 30, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE FLEXOR SHEATH FROM A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET WAS DAMAGED. THE DEVICE WAS REQUIRED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. WHEN RINSING THE PRODUCT, IT WAS FOUND THAT THE TIP OF THE FLEXOR SHEATH WAS BROKEN AND COULD NOT BE USED. THE DEVICE WAS REPLACED WITH A NEW LIKE-DEVICE TO COMPLETE THE PROCEDURE. THE DAMAGED DEVICE WAS DISCARDED BY THE HOSPITAL. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117283 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT THE FLEXOR SHEATH INCLUDED IN THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET BROKE AT THE SHAFT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE FOR A 53-YEAR-OLD MALE PATIENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 WITH A HISTORY OF LIVER CIRRHOSIS AND ESOPHAGEAL VARICES. ON (B)(6) 2024, AFTER INSERTING THE DEVICE PERCUTANEOUSLY, THE HEMOSTATIC VALVE SEPARATED FROM THE INTRODUCER SHEATH. UPON NOTING THIS SEPARATION, THE PRODUCT WAS IMMEDIATELY REPLACED WITH A NEW DEVICE TO CONTINUE THE PROCEDURE. THE ONLY COMPONENT ADVANCED THROUGH THE SHEATH WHEN IT BROKE WAS THE STYLET. CUSTOMER PROVIDED PHOTO REVEALS SHEATH SHAFT SEPARATED NEAR THE FLARE OF THE CHECK FLO VALVE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977634 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE FLEXOR SHEATH INCLUDED IN THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET BROKE DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE ON A 69-YEAR-OLD FEMALE PATIENT. FOLLOWING COMPLETION OF PREOPERATIVE PREPARATION, THE JUGULAR VEIN WAS PUNCTURED USING A COMPETITOR'S MICRO PUNCTURE SHEATH. A WIRE GUIDE WAS THEN INSERTED, FOLLOWED BY THE INTRODUCTION OF A CONTRAST CATHETER FOR PORTAL VENOGRAPHY. AFTER PERFORMING PORTAL VENOGRAPHY, THE CONTRAST CATHETER WAS WITHDRAWN, AND DILATION OF THE ACCESS ROUTE WAS PERFORMED ALONG THE WIRE GUIDE USING A 10F SHEATH SET. UPON WITHDRAWAL OF THE INNER CORE, THE SUPPORT SET AND PUNCTURE SET WERE INTRODUCED. WHILE CONFIRMING THE PUNCTURE DIRECTION AND PREPARING TO PUNCTURE THE JUGULAR VEIN WITH THE PUNCTURE SET, THE 10F OUTER SHEATH FRACTURED AT THE CONNECTION WITH THE HEMOSTASIS VALVE, MAKING IT UNUSABLE. THE 10F SHEATH WAS REPLACED WITH A NEW SAME LIKE-DEVICE BUT THE SAME ISSUE RECURRED, WITH THE SHEATH FRACTURING AT THE CONNECTION WITH THE HEMOSTASIS VALVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THE DEFECTIVE SHEATH WITH ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754113 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE FLEXOR SHEATH INCLUDED IN THE ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET BROKE DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE IN A 69-YEAR-OLD FEMALE PATIENT. FOLLOWING COMPLETION OF PREOPERATIVE PREPARATION, THE JUGULAR VEIN WAS PUNCTURED USING A COMPETITOR'S MICRO PUNCTURE SHEATH. A WIRE GUIDE WAS THEN INSERTED, FOLLOWED BY THE INTRODUCTION OF A CONTRAST CATHETER FOR PORTAL VENOGRAPHY. AFTER PERFORMING PORTAL VENOGRAPHY, THE CONTRAST CATHETER WAS WITHDRAWN, AND DILATION OF THE ACCESS ROUTE WAS PERFORMED ALONG THE WIRE GUIDE USING A 10F SHEATH SET. UPON WITHDRAWAL OF THE INNER CORE, THE SUPPORT SET AND PUNCTURE SET WERE INTRODUCED. WHILE CONFIRMING THE PUNCTURE DIRECTION AND PREPARING TO PUNCTURE THE JUGULAR VEIN WITH THE PUNCTURE SET, THE 10F OUTER SHEATH FRACTURED AT THE CONNECTION WITH THE HEMOSTASIS VALVE, MAKING IT UNUSABLE. THE 10F SHEATH WAS REPLACED WITH A NEW SAME LIKE-DEVICE, BUT THE SAME ISSUE RECURRED, WITH THE SHEATH FRACTURING AT THE CONNECTION WITH THE HEMOSTASIS VALVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING THE DEFECTIVE SHEATH WITH ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753824 ↗
• MalfunctionMar 14, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BLUE CATHETER FROM A ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET COULD NOT BE ADVANCED INTO THE STIFFENING CANNULA DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN OF THE DEVICE AND VISUAL EXAMINATION ON 04MAR2025, THE TIP OF THE FLEXOR SHEATH WAS NOTED TO BE DAMAGED; THUS, PROMPTING THIS REPORT. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606839 ↗