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

Model Number	24701
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior tibial artery.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during the procedure, the balloon catheter bent or folded on itself, and seemed to separate from the wire but was very difficult to remove.The device was removed intact, and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: changed from 12/04/2023 to 11/22/2023.Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that removal difficulty was encountered.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior tibial artery.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during the procedure, the balloon catheter bent or folded on itself, and seemed to separate from the wire but was very difficult to remove.The device was removed intact, and the procedure was completed with another of same device.No patient complications were reported.

• Brand Name: COYOTE ES
• 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: 18352449
• Report Number: 2124215-2023-71336
• Device Sequence Number: 8406722
• Product Code: LIT
• UDI-Device Identifier: 08714729767411
• UDI-Public: 08714729767411
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093636
• 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): 12/25/2023

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: 05/08/2025
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0031583659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 12/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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 Age: 75 YR
• Patient Sex: Female