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

Model Number	H74939135202010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported balloon leak occurred.Patient was presented with pulmonary hypertension.The target lesion was located in the pulmonary artery.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.During inflation, it was noted that the balloon leak air.The balloon was replaced and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).With the available information, boston scientific concludes: device history record (dhr) review it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis the coyote device was returned for evaluation.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed the shaft of the catheter had a burst at 24cm from the tip.Multiple kinks were found along the shaft of the catheter on the shaft.No other issues were identified during the product analysis.Labeling review review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion boston scientific concludes the most probable root cause as unable to exclude device problem because although the device was returned and a rupture was confirmed, not enough information was able to be provided by the site to determine a more probable cause.
Event or Problem Description
It was reported balloon leak occurred.Patient was presented with pulmonary hypertension.The target lesion was located in the pulmonary artery.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.During inflation, it was noted that the balloon leak air.The balloon was replaced and the procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24165027
• Report Number: 2124215-2026-04306
• Device Sequence Number: 9205026
• Product Code: LIT
• UDI-Device Identifier: 08714729767176
• UDI-Public: (01)08714729767176(17)280207(10)35803333
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093636
• 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): 03/16/2026

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: 0035803333
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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 Age: 78 YR
• Patient Sex: Male