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

Model Number 24691

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous superficial femoral artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, during second inflation, before reaching the rated burst pressure, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was in good condition.

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous superficial femoral artery.A 4mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, during second inflation, before reaching the rated burst pressure, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient was in good condition.

Manufacturer Narrative

(f10) device code: removed device code 2524- failure to advance.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11167459
• MDR Text Key: 226800111
• Report Number: 2134265-2021-00295
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767312
• UDI-Public: 08714729767312
• Combination Product (y/n): N
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0025073685
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1