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

Model Number 24691

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first day of the month of aware date as there was no date provided.Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The inner shaft was buckled 70mm from the tip.There was a hole in the inner shaft in the buckled area, and a hole in the outer shaft at 74mm from the tip.The hole was consistent with an interaction with a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on 24mar2020.It was reported that tracking difficulties were encountered.A 2mm x 40mm x 145cm coyote balloon catheter was selected for use.However, the device would not advance over the wire.The wire would not come though the monorail port.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed an outer shaft hole.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9967465
• MDR Text Key: 187877939
• Report Number: 2134265-2020-04368
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: 08714729767190
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0024628589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1