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

Model Number	24704
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 target lesion was located in the calcified ulnar artery.A 3.5mm x 80mm x 90cm coyote balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with a non-bsc device.No further patient complications were 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: 11476471
• Report Number: 2134265-2021-03283
• Device Sequence Number: 19814651
• Product Code: DQY
• UDI-Device Identifier: 08714729796602
• UDI-Public: 08714729796602
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: 05/14/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0025512762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR