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

Model Number	24706
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon protector dislodged inside the patient.A coyote balloon was selected for use in the tibioperoneal trunk to treat stenosis.The coyote balloon was passed to the tibioperoneal trunk.However, there was difficulty advancing the balloon any further.The balloon was attempted to be advanced several times by retracting the balloon catheter and then advancing forward.The balloon though, would not advance further.It was decided to exchange the balloon for a smaller coyote balloon.The new balloon was prepped.On fluoro, an artifact was observed.The second coyote balloon was advanced over the guidewire to the tibial peroneal trunk.At the same location, there was also difficulty advancing this balloon.Despite several attempts, it could not advance.The guidewire and balloon catheter were removed together.It was then decided to ivus the area to determine if something was left inside the patient.A surgeon was called it to remove it.Ivus found nothing, and the surgeon would not open up the artery without confirmation of a detached component.It was thought that the second balloon was advanced into the dislodged balloon protector.The balloon was then jammed into the balloon protector during advancement.When it was removed, so was the balloon protector.The procedure was completed.

• 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: 17351827
• Report Number: 2124215-2023-34197
• Device Sequence Number: 6042227
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/19/2023

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: 12/04/2025
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0030648892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown