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

Model Number	H74939134204010
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that the balloon ruptured and separated inside the patient, requiring a snare for removal.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified peripheral artery (pa).A 2mm x 40mm x 144cm coyote es was advanced for dilation.During the procedure, upon inflating the device, the balloon ruptured.Upon removal, the balloon got caught on the nodule and was separated inside the patient.All of the separated parts were able to be retrieved with a snare, so no fragments remained inside the patient.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the balloon ruptured and separated inside the patient, requiring a snare for removal.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified peripheral artery (pa).A 2mm x 40mm x 144cm coyote es was advanced for dilation.During the procedure, upon inflating the device, the balloon ruptured.Upon removal, the balloon got caught on the nodule and was separated inside the patient.All of the separated parts were able to be retrieved with a snare, so no fragments remained inside the patient.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - (b)(6).Device evaluated by mfr: the coyote es balloon catheter 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 that the ballon is separated 147.2cm from the hub.The guidewire lumen is separated 156.1cm from the hub and appears to have been stretched prior to separating.The distal end of the separated balloon and guidewire lumen returned in 3 pieces.There is multiple buckling along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the balloon and guidewire lumen is separated.

• 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: 21632903
• Report Number: 2124215-2025-13880
• Device Sequence Number: 12632580
• Product Code: LIT
• UDI-Device Identifier: 08714729767350
• UDI-Public: (01)08714729767350(17)260402(10)33739084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: H74939134204010
• Device Catalogue Number: H74939134204010
• Device Lot Number: 0033739084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown