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

Model Number 24691

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that catheter entrapment occurred.The 99% stenosed target lesion was located in a moderately calcified and mildly tortuous vessel below the knee.After a non- bsc guide wire crossed the lesion, a 2mm x 40mm x 145cm coyote es balloon catheter was advanced for pre-dilatation.However, the balloon catheter did not advance at the area before the lesion, and it became stuck with the wire.The device was remove together as a whole system.The procedure was completed with a non-bsc device.No patient complications were reported.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8464935
• MDR Text Key: 140333338
• Report Number: 2134265-2019-03180
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: 08714729767190
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0022136128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2018
• 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