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

Model Number	H74939186351510
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that froze on wire and balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery of the right lower limb.A 014 x 300 cm non-boston scientific 014 guidewire was used to cross the lesion successfully.After guidewire placement, a 3.5 mm x 150 mm x 150 cm, otw coyote balloon catheter was prepared and advanced over the guidewire without difficulty.The balloon was inflated at the lesion without issues.However, resistance was encountered during withdrawal; the balloon could not retract over the guidewire and had to be removed together as a single unit, resulting in loss of access to the lesion.Once outside the patient, attempts to separate the balloon from the guidewire were unsuccessful.Based on the attached photo, the balloon was confirmed to have ruptured.The procedure was completed with another of same device.The patients condition post-procedure was stable.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that froze on wire and balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery of the right lower limb.A 014 x 300 cm non-boston scientific 014 guidewire was used to cross the lesion successfully.After guidewire placement, a 3.5 mm x 150 mm x 150 cm, otw coyote balloon catheter was prepared and advanced over the guidewire without difficulty.The balloon was inflated at the lesion without issues.However, resistance was encountered during withdrawal; the balloon could not retract over the guidewire and had to be removed together as a single unit, resulting in loss of access to the lesion.Once outside the patient, attempts to separate the balloon from the guidewire were unsuccessful.Based on the attached photo, the balloon was confirmed to have ruptured.The procedure was completed with another of same device.The patients condition post-procedure was stable.It was further reported that the patient had lesions of moderate severity, and the anatomy was not considered challenging.No patient or lesion factors contributed to the occurrence of this event.The procedure was managed in the standard manner, and procedural factors did not contribute to the event; the other balloons used did not present any difficulties.The patient successfully regained perfusion in the lower limb due to additional interventions.
Additional Manufacturer Narrative
Updated b5 - describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that froze on wire and balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified posterior tibial artery of the right lower limb.A 014 x 300 cm non-boston scientific 014 guidewire was used to cross the lesion successfully.After guidewire placement, a 3.5 mm x 150 mm x 150 cm, otw coyote balloon catheter was prepared and advanced over the guidewire without difficulty.The balloon was inflated at the lesion without issues.However, resistance was encountered during withdrawal; the balloon could not retract over the guidewire and had to be removed together as a single unit, resulting in loss of access to the lesion.Once outside the patient, attempts to separate the balloon from the guidewire were unsuccessful.Based on the attached photo, the balloon was confirmed to have ruptured.The procedure was completed with another of same device.The patients condition post-procedure was stable.It was further reported that the patient had lesions of moderate severity, and the anatomy was not considered challenging.No patient or lesion factors contributed to the occurrence of this event.The procedure was managed in the standard manner, and procedural factors did not contribute to the event; the other balloons used did not present any difficulties.The patient successfully regained perfusion in the lower limb due to additional interventions.It was further reported that the physician performed a new lower-limb angioplasty using a coyote balloon of similar size to the initial one.

• Brand Name: COYOTE?
• 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: 23698192
• Report Number: 2124215-2025-84987
• Device Sequence Number: 10192462
• Product Code: LIT
• UDI-Device Identifier: 08714729796749
• UDI-Public: (01)08714729796749(17)261214(10)33064775
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111295
• 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): 01/12/2026

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: H74939186351510
• Device Catalogue Number: H74939186351510
• Device Lot Number: 0033064775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/17/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/12/2026
• Date Device Manufactured: 12/15/2023
• 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: COMMAND 014X300CM ABBOTT; GUIDEWIRE: COMMAND 014X300CM ABBOTT; GUIDEWIRE: COMMAND 014X300CM ABBOTT
• Patient Age: 76 YR
• Patient Sex: Female