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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.After a 300 cm victory guide wire crossed the lesion, a 2.5mm x 80mm x 150cm coyote balloon catheter was advanced for dilatation.However, the wire became stuck with the balloon shaft and it would not move, when both devices were compatible.According to the technician, the guide wire and the balloon catheter may have not properly flushed.The procedure was completed with another wire and balloon catheter.No 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: 8449189
• Report Number: 2134265-2019-02805
• Device Sequence Number: 429340
• Product Code: DQY
• UDI-Device Identifier: 08714729797180
• UDI-Public: 08714729797180
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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: 10/23/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0022833919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1