MalfunctionMPB
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
Received May 4, 2026 · Event occurred Apr 3, 2026
Report 3006425876-2026-00478 · MDR key 25072096
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25122-F
Lot number
71F25H1253
Product problems
- Difficult to Remove
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, "DURING A CATHETERIZATION PROCEDURE, THE CATHETER WAS SUCCESSFULLY POSITIONED AT THE TARGET LOCATION. UPON REMOVAL, THE GUIDEWIRE WAS OBSERVED TO BE KINKED AND BECAME UNUSABLE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO ANOTHER DEVICE.
Additional Manufacturer Narrative
(B)(4).