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

Model Number	24706
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel below the right knee.After a 4.5 non-boston scientific introducer sheath and micro catheter were placed, and a guidewire crossed the lesion, a 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for dilation.The balloon was initially inflated at 8 atmospheres (atm).When the pressure was increased from 12atm to 14atm on the second dilation, the balloon ruptured.The procedure was completed using a 2.5x240 non-bsc balloon catheter inflated at about 18atm.There were no patient complications nor injuries reported.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11518545
• Report Number: 2134265-2021-03243
• Device Sequence Number: 3828377
• Product Code: DQY
• UDI-Device Identifier: 08714729796718
• UDI-Public: 08714729796718
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 11/17/2023
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0026377471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1