MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Coyote; catheter, angioplasty, peripheral, transluminal

Model Number	24698
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 4.0mm x 150mm x 150cm mr coyote balloon catheter was advanced for dilation.However, during the third inflation at 14 atmospheres for several seconds, the balloon ruptured in a vertical form and a damaged surface appeared on the main unit.The device was removed, and the procedure was completed with a different device.No patient complications were reported, and the patient was in good condition.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 17842776
• Report Number: 2124215-2023-53495
• Device Sequence Number: 17221577
• Product Code: DQY
• UDI-Device Identifier: 08714729797098
• UDI-Public: 08714729797098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111295
• 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,Followup
• Report Date (Section B): 09/30/2026

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 Expiration Date: 11/27/2025
• Device Model Number: 24698
• Device Catalogue Number: 24698
• Device Lot Number: 0030611767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE, 014 GW; INFLATION DEVICE, NIPRO; INTRODUCER SHEATH, 6F DESTINATION
• Patient Sex: Unknown