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

Model Number	24704
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with chronic critical limb ischemia and underwent vascular intervention.The 100% stenosed target lesion was located in the severely calcified and severely tortuous distal tibial vessel.A 2.0mm x 80mm x 150cm coyote balloon catheter and a 1.5mm x 20mm x 142cm coyote es balloon catheter were each advanced for dilatation but had difficulty crossing the lesion and both balloons ruptured during the initial inflation.No device fragments were left inside the patient and the procedure was completed with another coyote balloon catheter.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with chronic critical limb ischemia and underwent vascular intervention.The 100% stenosed target lesion was located in the severely calcified and severely tortuous distal tibial vessel.A 2.0mm x 80mm x 150cm coyote balloon catheter and a 1.5mm x 20mm x 142cm coyote es balloon catheter were advanced for dilatation but had difficulty crossing the lesion and both balloons ruptured during the initial inflation.No device fragments were left inside the patient and the procedure was completed with another coyote balloon catheter.No patient complications were reported.It was further reported that the 1.5mm x 20mm x 142cm coyote es balloon catheter crossed the lesion; however, it burst as it was being inflated at about 8 atmospheres.The 2.0mm x 80mm x 150cm coyote balloon catheter did not cross the lesion and was not inflated.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15869264
• Report Number: 2124215-2022-49009
• Device Sequence Number: 14754848
• Product Code: DQY
• UDI-Device Identifier: 08714729796428
• UDI-Public: 08714729796428
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 12/27/2022

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: 09/01/2025
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0030073913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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
• Patient Sex: Unknown