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

Model Number	24705
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event date was not reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that during an angioplasty procedure, the distal end of the balloon disconnected from the catheter and became stuck on the wire.

• 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: 10896319
• Report Number: 2134265-2020-16163
• Device Sequence Number: 2896000
• Product Code: DQY
• UDI-Device Identifier: 08714729796442
• UDI-Public: 08714729796442
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 07/18/2021
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0022397527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1