MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, PERCUTANEOUS

Model Number	H74939185402210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): lit.G4 - premarket / 510(k) #: k162350.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the anterior tibial artery.After crossing the guidewire, a 4.0mm x 220mm x 150cm, mr coyote balloon catheter was advanced for dilation.However, due to the presence of severe calcification, the balloon ruptured during the initial inflation at 8 atmospheres.The procedure was completed with another of same device.No patient complications nor injuries were reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 21403475
• Report Number: 2124215-2025-09521
• Device Sequence Number: 8215256
• Product Code: DQY
• UDI-Device Identifier: 08714729796404
• UDI-Public: 08714729796404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 02/18/2025

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: H74939185402210
• Device Catalogue Number: H74939185402210
• Device Lot Number: 0032679712
• 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: 01/23/2025
• Initial Report FDA Received Date: 02/18/2025
• Date Device Manufactured: 10/20/2023
• 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
• Patient Sex: Unknown