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

Model Number	H74939185302210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: additional pro code (product code): lit.G4: additional premarket / 510(k): k162350.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified anterior tibial artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.During second inflation at 6 atmospheres for 3 seconds, the balloon ruptured in a pinhole form at the distal, near the tip.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported, and the patient was in good condition post 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: 21127175
• Report Number: 2124215-2025-00756
• Device Sequence Number: 6829770
• Product Code: DQY
• UDI-Device Identifier: 08714729796961
• UDI-Public: 08714729796961
• 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): 01/10/2025

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 Expiration Date: 12/21/2024
• Device Model Number: H74939185302210
• Device Catalogue Number: H74939185302210
• Device Lot Number: 0028603104
• 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: 12/23/2024
• Initial Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 12/22/2021
• 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