COYOTE? ES
Received Jun 29, 2026 · Event occurred May 7, 2026
Report 2124215-2026-34505 · MDR key 25654049
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939135304010Catalog number
H74939135304010
Lot number
0038562704
Product problems
- Difficult to Remove
- Material Rupture
Patient
NA · Unknown
- 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 BALLOON RUPTURED AND REMOVAL DIFFICULTY OCCURRED. A 3MM X 40MM X 146CM COYOTE ES WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED IN A CALCIFIED ARTERY. DURING REMOVAL, PART OF THE SHEATH REMAINED CAUGHT ON THE GUIDEWIRE AND THE TIP OF THE BALLOON REMAINED ATTACHED TO THE GUIDEWIRE. IMMEDIATE ACTION WAS PERFORMED BY REMOVING THE GUIDEWIRE FROM THE PATIENT. IT WAS NOTED THAT THE PROCEDURE WAS INTERRUPTED. THERE WERE MINOR CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.