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

Model Number	H74939135202010
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of below the knee.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.During first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter address 1: (b)(6).E1 - initial reporter city: (b)(6).Investigation results: device technical analysis upon receipt at our post market quality assurance laboratory, the outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed the balloon had a rupture and a kink on the inner shaft at 2cm from the tip.Microscopic examination revealed that the balloon ruptured along the proximal marker band area.No other issues were identified during the product analysis.Device history record (dhr) review it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel of below the knee.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.During first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.There were no patient complications as a result of this event.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24109251
• Report Number: 2124215-2026-03372
• Device Sequence Number: 17589849
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: (01)08714729767176(17)280901(10)37346664
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: H74939135202010
• Device Catalogue Number: H74939135202010
• Device Lot Number: 0037346664
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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: GUIDEWIRE: GLADIUS; GUIDEWIRE: GLADIUS; INFLATION DEVICE: GM30; INFLATION DEVICE: GM30; INTRODUCER SHEATH: TERUMO; INTRODUCER SHEATH: TERUMO; MICRO CATHETER: SARGENT; MICRO CATHETER: SARGENT
• Patient Sex: Unknown