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

Model Number	H74939186301510
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a mildly tortuous and mildly calcified vessel.A 3.0mm x 150mm x 150cm coyote catheter was advanced for dilation.During the procedure, the balloon ruptured.A 3mm x 150mm coyote balloon was used successfully during the first angioplasty.After being removed to cannulate the anterior tibial artery, the balloon ruptured when reinserted due to coming out between the catheter and balloon.The balloon was purged outside the patient, revealing a leak in the middle section.A visible puncture was found on the balloon, and it was replaced with a new one.No guide catheter was used during the procedure.The device was removed without any problem, and the procedure was completed with a different device.No complications were reported.
Additional Manufacturer Narrative
The coyote was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed two kinks on the shaft at 71cm and 72cm.There was also tip damage found and a hole in the inner shaft inside the balloon at 8cm causing a leak through the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a mildly tortuous and mildly calcified vessel.A 3.0mm x 150mm x 150cm coyote catheter was advanced for dilation.During the procedure, the balloon ruptured.A 3mm x 150mm coyote balloon was used successfully during the first angioplasty.After being removed to cannulate the anterior tibial artery, the balloon ruptured when reinserted due to coming out between the catheter and balloon.The balloon was purged outside the patient, revealing a leak in the middle section.A visible puncture was found on the balloon, and it was replaced with a new one.No guide catheter was used during the procedure.The device was removed without any problem, and the procedure was completed with a different device.No complications were reported.

• 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: 20955853
• Report Number: 2124215-2024-79764
• Device Sequence Number: 18054037
• Product Code: DQY
• UDI-Device Identifier: 08714729796589
• UDI-Public: 08714729796589
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 03/04/2025

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: 12/06/2025
• Device Model Number: H74939186301510
• Device Catalogue Number: H74939186301510
• Device Lot Number: 0030665136
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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
• Patient Sex: Unknown