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

Model Number	24699
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified right anterior tibial artery.A 4.0mm x 220mm x 150cm coyote es balloon was advanced for dilatation.During the procedure, the device was stuck at the lesion and the catheter shaft got separated inside the patient.The fragment was held in placed and pulled out, and the procedure was completed with a different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
H6 device codes updated from break (a0401) to material rupture (a0412).
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified right anterior tibial artery.A 4.0mm x 220mm x 150cm coyote es balloon was advanced for dilatation.During the procedure, the device was stuck at the lesion and the catheter shaft got separated inside the patient.The fragment was held in placed and pulled out, and the procedure was completed with a different device.No patient complications nor injuries were reported.It was further reported that the 4.0mm x 220mm x 150cm coyote es balloon catheter was ruptured at the central part during first inflation at 10 atmospheres and not separated as previously reported.The target lesion was located in the superficial femoral artery.

• 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: 17244788
• Report Number: 2124215-2023-34440
• Device Sequence Number: 4871726
• Product Code: DQY
• UDI-Device Identifier: 08714729796404
• UDI-Public: 08714729796404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 01/12/2026
• Device Model Number: 24699
• Device Catalogue Number: 24699
• Device Lot Number: 0030844803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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