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

Model Number	24706
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the coyote was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination showed no issues; however, the device was received with a guidewire stuck inside.The guidewire was able to be removed using force and pulling.It was unable to feed the guidewire through.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the guidewire being stuck.
Event or Problem Description
It was reported that froze on wire occurred.The 80% stenosed target lesion was located in the mild tortuous and mild calcified anterior tibial artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.During the procedure, it was found that the shaft was crimped.The balloon was advanced and inflated at 8atm for 2 minutes.The device was withdrawn and reinserted after laser atherectomy on wire.However, the balloon would not track over wire and wire could not be removed either.The wire and balloon were removed from the patient intact and fully deflated 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: 19508788
• Report Number: 2124215-2024-34911
• Device Sequence Number: 18021261
• Product Code: DQY
• UDI-Device Identifier: 08714729797265
• UDI-Public: 08714729797265
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/11/2024

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: 09/21/2026
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0032481362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: GUIDE CATHETER - 5 FR. DESTINATION.; GUIDEWIRE - .014 ASAHI MONGO.
• Patient Sex: Male