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

Model Number	H74939185251510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): lit.E1 - initial reporter city: (b)(6).G4 - premarket / 510(k) #: k162350.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed, chronically totally occluded (cto) target lesion was located in the moderately tortuous and moderately calcified below-the-knee vessel.After the 014 guidewire was able to cross the cto, a 2.5mm x 150mm x 150cm, mr coyote balloon catheter was advanced into the lesion.However, a balloon rupture occurred before inflation.The device was removed, and the procedure was completed with a different device.No patient complications were reported, and the patient was in good condition after the procedure.

• 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: 21302188
• Report Number: 2124215-2025-04783
• Device Sequence Number: 8848020
• Product Code: DQY
• UDI-Device Identifier: 08714729796886
• UDI-Public: 08714729796886
• 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): 02/04/2025

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: H74939185251510
• Device Catalogue Number: H74939185251510
• Device Lot Number: 0032593696
• 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: 01/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 10/09/2023
• 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: INFLATION DEVICE USED: NIPRO; INTRODUCER SHEATH USED: 4.5F PARENT PLUS
• Patient Sex: Unknown