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

Model Number	24705
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became stuck with the wire and then peeled away from the wire.A coyote balloon was selected for an arterial procedure.While loading balloon on to the wire it was sticking, but they managed to use it for the case.However, when they tried to remove it off of the wire, it was stuck.It then peeled away from the wire while removing it from inside of the patient.This was the only way they were able to remove it.Patient was fine.Another of the same device was used to complete the procedure.The patient condition after the procedure was stable.

• 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: 8541273
• Report Number: 2134265-2019-04187
• Device Sequence Number: 373759
• Product Code: DQY
• UDI-Device Identifier: 08714729796725
• UDI-Public: 08714729796725
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/23/2019

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: 09/19/2021
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0022680018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1