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

Model Number	H74939135302010
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional event and patient details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the balloon ruptured and detached.A coyote es balloon was selected for use.During the procedure, the balloon ruptured and detached from the catheter.
Event or Problem Description
It was reported that the balloon ruptured and detached.A coyote es balloon was selected for use.During the procedure, the balloon ruptured and detached from the catheter.It was further reported that the balloon was removed together with the catheter.The procedure was continued with another balloon catheter.There were no patient complications as a result of the event.
Event or Problem Description
It was reported that the balloon ruptured and detached.A coyote es balloon was selected for use.During the procedure, the balloon ruptured and detached from the catheter.Additional event and patient details were not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.It was further reported that the balloon was removed together with the catheter.The procedure was continued with another balloon catheter.There were no patient complications as a result of the event.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis completed.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen is separated 25.3cm from the tip while the guidewire lumen is separated 27.3cm from the tip.Microscopic examination revealed that the guidewire lumen and inflation lumen is torn 21cm from the tip to the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 22939018
• Report Number: 2124215-2025-60656
• Device Sequence Number: 13231364
• Product Code: LIT
• UDI-Device Identifier: 08714729767237
• UDI-Public: (01)08714729767237(17)270212(10)33411404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/28/2025

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: H74939135302010
• Device Catalogue Number: H74939135302010
• Device Lot Number: 0033411404
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 10/22/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/25/2025; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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
• Patient Sex: Unknown