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

Model Number	H74939186301510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon rupture occurred.The patient underwent lower limb angioplasty procedure.A 3.0mm x 150mm x 150cm, otw coyote? balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon was inflated to 6 atmospheres and was rupture to greater than the nominal pressure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed information was not provided to bsc.A good-faith effort was made to acquire the necessary information.Since we are unable to provide specific details at this time, a supplemental report will be submitted if additional information becomes available in the future.
Additional Manufacturer Narrative
Detailed information was not provided to bsc.A good-faith effort was made to acquire the necessary information.Since we are unable to provide specific details at this time, a supplemental report will be submitted if additional information becomes available in the future.Device evaluated by mfr: the coyote was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear 31mm from the tip and is approximately 9mm long.
Event or Problem Description
It was reported that a balloon rupture occurred.The patient underwent lower limb angioplasty procedure.A 3.0mm x 150mm x 150cm, otw coyote? balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon was inflated to 6 atmospheres and ruptured at greater than the nominal pressure.There were no patient complications as a result of this event.

• 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: 22090760
• Report Number: 2124215-2025-34381
• Device Sequence Number: 6906760
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: (01)08714729796589(17)270806(10)34582552
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: H74939186301510
• Device Catalogue Number: H74939186301510
• Device Lot Number: 0034582552
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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