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

Model Number	H74939134204010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the non-tortuous and mildly calcified lower extremity artery.A 2mm x 40mm x 144cm coyote es balloon was advanced for dilation.However, during the first inflation, it was noted that the balloon ruptured.The device was removed and the procedure was completed using an alternate device.No complications were reported, and the patient is expected to fully recover.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the non-tortuous and mildly calcified lower extremity artery.A 2mm x 40mm x 144cm coyote es balloon was advanced for dilation.However, during the first inflation, it was noted that the balloon ruptured.The device was removed and the procedure was completed using an alternate device.No complications were reported, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft burst 6cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a rupture in the shaft.

• 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 ; 6128757234
• MDR Report Key: 21035614
• Report Number: 2124215-2024-82292
• Device Sequence Number: 8419718
• Product Code: LIT
• UDI-Device Identifier: 08714729767350
• UDI-Public: 08714729767350
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2025

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 Expiration Date: 05/01/2026
• Device Model Number: H74939134204010
• Device Catalogue Number: H74939134204010
• Device Lot Number: 0033941812
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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