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

Model Number	H74939134204010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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 mildly tortuous and severely calcified vessel below the knee.A 2mm x 40mm x 144cm coyote otw balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with highlander balloon catheter of the same diameter.No patient injuries reported, and the patient condition was good post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 44mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified vessel below the knee.A 2mm x 40mm x 144cm coyote otw balloon catheter was advanced for dilatation.However, during first inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with highlander balloon catheter of the same diameter.No patient injuries reported, and the patient condition was good post-procedure.

• 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: 22783279
• Report Number: 2124215-2025-54561
• Device Sequence Number: 9869598
• Product Code: LIT
• UDI-Device Identifier: 08714729767350
• UDI-Public: (01)08714729767350(17)261115(10)35289278
• 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): 09/04/2025

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: H74939134204010
• Device Catalogue Number: H74939134204010
• Device Lot Number: 0035289278
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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: GUIDEWIRE USED: GRADIUS; GUIDEWIRE USED: GRADIUS; INTRODUCER SHEATH USED: 4FR SHEATH; INTRODUCER SHEATH USED: 4FR SHEATH
• Patient Sex: Unknown