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

Model Number	H74939134202010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 2mm x 20mm x 142cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 5 seconds.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.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the 2mm x 20mm x 142cm coyote es device was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon was functionally tested by inflating it to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported balloon rupture.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: 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.Risk review: a risk review performed for the 2mm x 20mm x 142cm coyote es device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 2mm x 20mm x 142cm coyote es balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 5 seconds.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.

• 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: 24720596
• Report Number: 2124215-2026-17071
• Device Sequence Number: 6087838
• Product Code: LIT
• UDI-Device Identifier: 08714729767336
• UDI-Public: (01)08714729767336(17)270415(10)36301816
• 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
• Report Date (Section B): 04/23/2026

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: H74939134202010
• Device Catalogue Number: H74939134202010
• Device Lot Number: 0036301816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: BALLOON CATHETER - COYOTE; BALLOON CATHETER - COYOTE; GUIDE CATHETER - MACH1; GUIDE CATHETER - MACH1; GUIDEWIRE - JUPITERS6; GUIDEWIRE - JUPITERS6; INFLATION DEVICE - GM30; INFLATION DEVICE - GM30; INTRODUCER SHEATH - TERUMO; INTRODUCER SHEATH - TERUMO; MICRO CATHETER - ARMET; MICRO CATHETER - ARMET
• Patient Sex: Unknown