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

Model Number	24696
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	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was entrapped on the wire.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery.A 2.0mm x 100mm x 150cm coyote balloon catheter and a 0.014 fathom guidewire were selected use in a below-the-knee percutaneous transluminal angioplasty procedure (pta).During the procedure, the coyote balloon catheter was advanced over the fathom guidewire.However, resistance was felt just below the knee joint and the coyote balloon catheter could not advance further.Removal was attempted but the balloon became entrapped on the fathom guidewire.The balloon catheter and guidewire were removed together.The physician observed that the tip of the balloon was damaged.The procedure was completed with another pta balloon and guidewire.No complications were reported, and the patient was okay.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.The returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed buckling to the guidewire lumen 6.5cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon was entrapped on the wire.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery.A 2.0mm x 100mm x 150cm coyote balloon catheter and a 0.014 fathom guidewire were selected use in a below-the-knee percutaneous transluminal angioplasty procedure (pta).During the procedure, the coyote balloon catheter was advanced over the fathom guidewire.However, resistance was felt just below the knee joint and the coyote balloon catheter could not advance further.Removal was attempted but the balloon became entrapped on the fathom guidewire.The balloon catheter and guidewire were removed together.The physician observed that the tip of the balloon was damaged.The procedure was completed with another pta balloon and guidewire.No complications were reported, and the patient was okay.

• 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: 18595525
• Report Number: 2124215-2024-03361
• Device Sequence Number: 12477126
• Product Code: DQY
• UDI-Device Identifier: 08714729796787
• UDI-Public: 08714729796787
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: 05/14/2026
• Device Model Number: 24696
• Device Catalogue Number: 24696
• Device Lot Number: 0031616180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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
• Patient Sex: Unknown