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

Model Number	H74939186252210
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 36mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon which would cause failure to inflate.
Event or Problem Description
Reportable based on device analysis completed on 01may2025.It was reported that balloon inflation failure occurred.The 70% stenosed target lesion was located in the severely tortuous and moderately calcified anterior tibial artery.A 2.5mm x 220mm x 150cm coyote was advanced for dilation.However, during the procedure, it was noted that the balloon could not fully expand.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed a pinhole 36mm from the tip.

• Brand Name: COYOTE
• 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: 22060055
• Report Number: 2124215-2025-32545
• Device Sequence Number: 12844260
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/21/2025

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: H74939186252210
• Device Catalogue Number: H74939186252210
• Device Lot Number: 0035093705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: 66 YR
• Patient Sex: Male