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

Model Number	24704
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the right peroneal artery.A 2.0mm x 60mm x 150cm coyote balloon catheter was advanced for treatment; however, the balloon was stuck on a.014 non-bsc guidewire.Subsequently, both balloon and guidewire were removed together as one unit.No patient complications nor injuries were reported.The case was aborted until a later date.

• 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: 10451894
• Report Number: 2134265-2020-10700
• Device Sequence Number: 4283409
• Product Code: DQY
• UDI-Device Identifier: 08714729796732
• UDI-Public: 08714729796732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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: 06/26/2023
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0025645024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR