inforMED
MalfunctionFOZ

ARROW

Received May 7, 2026 · Event occurred Apr 15, 2026

Report 25111155 · MDR key 25111155

Device

Generic name

Catheter,intravascular,therapeutic,short-term Less Than 30 Days

Model number

IPN037948

Catalog number

ASK-45703-PUCI1

Lot number

33F25M0187

Patient

83 YR · Male

  • Insufficient Information

Narrative

Description of Event or Problem

MD WAS PLACING A FEMORAL TRIPLE LUMEN CATHETER, WHEN THE DISTAL END OF THE GUIDEWIRE BROKE DURING INSERTION, CAUSING THE WIRE TO "UNRAVEL." THE BROKEN PIECE WAS EXTERNAL TO THE PATIENT, AND THE MD WAS ABLE TO REMOVE THE ENTIRE GUIDEWIRE TO PREVENT INJURY TO THE PATIENT. ALL INFORMATION IN THIS REPORT REFERS TO THE INCIDENT ON [REDACTED]. AS A SIDE NOTE: THIS SAME EVENT OCCURRED IN [REDACTED]-THE BEGINNING OF THIS YEAR AT OUR SISTER CAMPUS (UNSURE IF REPORTED TO MEDSUN AT TIME OF INCIDENT). IT WAS REPORTED DURING THE [REDACTED] INCIDENT THAT "WHEN REMOVING THE GUIDE WIRE AFTER THREADING THE TRIPLE LUMEN OVER IT, THE GUIDEWIRE ESSENTIALLY BROKE DOWN INTO A THIN WIRE. MD WAS ABLE TO TAKE THE WHOLE GUIDEWIRE OUT, BUT IT WAS SUPER UNUSUAL THAT IT ESSENTIALLY TURNED INTO A VERY THIN WIRE." LOT # 33F25L0063, EXP 2027-01-31