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	02/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became entrapped on the guidewire.A 3.0mm x 100mm x 150cm coyote balloon catheter and a savion flx guidewire were selected for use for a peripheral intervention procedure of the right anterior tibial artery.During the procedure while inside the patient, the coyote balloon became stuck on the savion flx guidewire.Both devices were removed from the body together as a system and were then able to be separated.It was then observed that there was a kink on the guidewire at the point where the balloon was stuck.The procedure was completed using a new coyote balloon catheter and savion flx guidewire.There were no patient complications reported and the patient's status post procedure was fine.

• 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: 8409903
• Report Number: 2134265-2019-02294
• Device Sequence Number: 420351
• Product Code: DQY
• UDI-Device Identifier: 08714729796565
• UDI-Public: 08714729796565
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/11/2019

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: 10/30/2021
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 22868815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1