JETSTREAM XC Atherectomy Catheter
Received Jul 10, 2026 · Event occurred Jun 10, 2026
Report 2124215-2026-37092 · MDR key 25788528
Device
Generic name
Catheter, Peripheral, Atherectomy
Manufacturer
Boston Scientific CorporationModel number
45007Catalog number
45007
Lot number
0038818295
Product problems
- Unintended Movement
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER PHONE: (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT THE GUIDEWIRE MOVED FORWARD. A 2.1 MM JETSTREAM XC ATHERECTOMY CATHETER WAS USED DURING AN ILIAC ARTERY RESECTION PROCEDURE. SHORTLY AFTER THE JETSTREAM CATHETER ENTERED THE VESSEL, THE THRUWAY GUIDEWIRE MOVED FORWARD AND BACKWARD, PREVENTING THE RESECTION FROM CONTINUING. THE PHYSICIAN WITHDREW BOTH THE CATHETER AND GUIDEWIRE, THEN COMPLETED THE PROCEDURE USING ANOTHER GUIDEWIRE AND BALLOONS. THE EVENT WAS RESOLVED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.