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

Model Number	24706
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coyote balloon was stuck on the wire.A contralateral access was gained via peroneal artery.A 3.5mm x 220mm x 150cm coyote balloon and 150 cm rubicon 14 were selected for use.During procedure, resistance was noted when rubicon device was advanced over a non bsc 0.14 wire.When the devices was advanced further the catheter buckled and the wire got kinked.The catheter and the wire were removed and replaced a larger catheter size and a new non bsc wire.Subsequently, the coyote balloon was advanced over a non bsc wire to the peroneal site.The balloon was inflated into a nominal pressure, however the balloon could not removed when trying to pull out.It go stuck on the wire.The physician attempted to remove the device by adding one bar of pressure.Finally with force they were able to remove the device from the patient's body.However, the balloon was separated from the catheter.The devices used were removed as a unit.Positioning was lost so the procedure was completed with a new non bsc wire to advance into the lesion and another of the same balloon to dilate the area.The procedure was completed without any further complications to the patient.

• 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: 8925179
• Report Number: 2134265-2019-10103
• Device Sequence Number: 18892803
• Product Code: DQY
• UDI-Device Identifier: 08714729797326
• UDI-Public: 08714729797326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/23/2019

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: 07/11/2022
• Device Model Number: 24706
• Device Catalogue Number: 24706
• Device Lot Number: 0024095921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1