MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Coyote? ES; Catheter, Angioplasty, Peripheral, Transluminal

Model Number	H74939135202010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and non-calcified pulmonary artery.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.The balloon was inflated multiple times at 10, 12, and 14 atmospheres for 30 seconds each; however, during the third inflation at 14 atmospheres, the balloon ruptured with a pinhole rupture.The rupture location could not be confirmed because the device was discarded.The balloon was removed using the normal method without difficulty, and another coyote es was used for further inflation.The procedure was completed successfully using different types of balloons.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was adverse event related to patient condition.

• Brand Name: Coyote? ES
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50270987
• Report Number: 2124215-2026-43906
• Device Sequence Number: 16098170
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: (01)08714729767176(17)290209(10)38562673
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: H74939135202010
• Device Catalogue Number: H74939135202010
• Device Lot Number: 0038562673
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 02/10/2026
• 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