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

Model Number	24704
Medical Device Problem Codes	Entrapment of Device (1212); Inflation Problem (1310); Material Twisted/Bent (2981); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon deflation issue occurred requiring additional intervention, and balloon became stuck with the wire.The more than 50% stenosed, 100 mm x 6 mm, straight and focal target lesion was located in the non-tortuous and non-calcified vessel.A 4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilatation.During the procedure, upon inflation to 6 atmospheres.The balloon would not inflate initially.The balloon was deflated and upon second inflation, the balloon would only partially inflate.Then the balloon would not deflate with inflating device.A larger syringe was used to deflate.When attempting to get the balloon to come back down the wire, the balloon would not advance in either direction.The balloon was attempted to pull back again; however, the wire broke from tension and the balloon had not moved.Both the wire and balloon were removed together.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
B5.Describe event or problem: added information.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple buckling to the guidewire lumen.Microscopic examination revealed no additional damages.Functional testing was performed, and the buckling appears to be restricting the flow to and from the balloon.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that the balloon deflation issue occurred requiring additional intervention, and balloon became stuck with the wire.The more than 50% stenosed, 100 mm x 6 mm, straight and focal target lesion was located in the non-tortuous and non-calcified vessel.A 4.0mm x 100mm x 150cm coyote balloon catheter was advanced for dilatation.During the procedure, upon inflation to 6 atmospheres.The balloon would not inflate initially.The balloon was deflated and upon second inflation, the balloon would only partially inflate.Then the balloon would not deflate with inflating device.A larger syringe was used to deflate.When attempting to get the balloon to come back down the wire, the balloon would not advance in either direction.The balloon was attempted to pull back again; however, the wire broke from tension and the balloon had not moved.Both the wire and balloon were removed together.The procedure was completed successfully.No patient complications were reported.It was further reported that the balloon was twisted.

• 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: 20560978
• Report Number: 2124215-2024-64279
• Device Sequence Number: 8802313
• Product Code: DQY
• UDI-Device Identifier: 08714729797364
• UDI-Public: 08714729797364
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0034161951
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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