MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE? ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939135404010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 8 atmospheres.The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 8 atmospheres.The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the balloon was inflated for about 5 seconds.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the coyote es was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 14mm from the tip and is approximately 24mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.
Additional Manufacturer Narrative
E1: initial reporter facility name :(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 8 atmospheres.The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the balloon was inflated for about 5 seconds.

• Brand Name: COYOTE? ES
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23617389
• Report Number: 2124215-2025-85429
• Device Sequence Number: 18641372
• Product Code: LIT
• UDI-Device Identifier: 08714729767312
• UDI-Public: (01)08714729767312(17)271202(10)35395105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939135404010
• Device Catalogue Number: H74939135404010
• Device Lot Number: 0035395105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 01/23/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/11/2025; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER - COYOTE; BALLOON CATHETER - COYOTE; BALLOON CATHETER - COYOTE; GUIDEWIRE - JUPITER; GUIDEWIRE - JUPITER; GUIDEWIRE - JUPITER; INTRODUCER SHEATH - CORDIS; INTRODUCER SHEATH - CORDIS; INTRODUCER SHEATH - CORDIS; NFLATION DEVICE - GM30; NFLATION DEVICE - GM30; NFLATION DEVICE - GM30; STENT - SMART RADIANZ; STENT - SMART RADIANZ; STENT - SMART RADIANZ
• Patient Sex: Unknown