inforMED
MalfunctionMPB

ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM

Received Dec 17, 2025 · Event occurred Nov 17, 2025

Report 3006425876-2025-01157 · MDR key 23828818

Device

Generic name

Catheter Hemodialytsis Non Imp

Catalog number

CS-22142-CF

Lot number

71F24K0955

Product problems

  • Difficult to Remove
  • Material Separation
  • Unraveled Material
  • Physical Resistance/Sticking
  • Difficult to Remove
  • Material Separation
  • Unraveled Material
  • Physical Resistance/Sticking

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2025, WHEN THE ICU DOCTOR AT (B)(6) HOSPITAL AFFILIATED TO (B)(6) IMPLANTED THE DEVICE, THE GUIDEWIRE GOT STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE WITHDRAWN. THEREFORE, THE GUIDEWIRE AND PUNCTURE NEEDLE HAD TO BE WITHDRAWN TOGETHER, AND A NEW CATHETER WAS RE-INSERTED FOR CATHETERIZATION. THE CUSTOMER SAID THE SWG UNRAVELED, NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. ASSOCIATED COMPLAINTS (B)(4) AND (B)(4).

Additional Manufacturer Narrative

(B)(4).

Additional Manufacturer Narrative

(B)(4). THE REPORT THAT THE GUIDEWIRE GOT STUCK IN THE NEEDLE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE GUIDEWIRE AND ONE INTRODUCER NEEDLE FOR EVALUATION. THE GUIDEWIRE WAS RETURNED PARTIALLY ADVANCED THROUGH THE NEEDLE AND WAS SEPARATED. THE CORE AND COIL WIRES WERE BROKEN NEAR THE DISTAL END. THE APPEARANCE OF THE SEPARATION POINTS IS CONSISTENT WITH DAMAGE RESULTING FROM RETRACTING THE GUIDEWIRE BACK UPON THE NEEDLE BEVEL DURING USE. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "WARNING: DO NOT WITHDRAW GUIDEWIRE AGAINST NEEDLE BEVEL TO REDUCE RISK OF POSSIBLE SEVERING OR DAMAGING OF GUIDEWIRE.". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. ARROW GUIDEWIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE REQUIRED STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE DIFFICULTY IN ADVANCING THE GUIDEWIRE. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT.

Description of Event or Problem

IT WAS REPORTED THAT: "ON (B)(6) 2025, WHEN THE ICU DOCTOR AT (B)(6) HOSPITAL AFFILIATED TO (B)(4) IMPLANTED THE DEVICE, THE GUIDEWIRE GOT STUCK IN THE PUNCTURE NEEDLE AND COULD NOT BE WITHDRAWN. THEREFORE, THE GUIDEWIRE AND PUNCTURE NEEDLE HAD TO BE WITHDRAWN TOGETHER, AND A NEW CATHETER WAS RE-INSERTED FOR CATHETERIZATION. THE CUSTOMER SAID THE SWG UNRAVELED, NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. ASSOCIATED COMPLAINTS 3006425876-2025-01157 AND 3006425876-2025-01160.".