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

Model Number 24691

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, during the initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed without any issue noted and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.

Event Description

It was reported that balloon rupture occurred.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, during the initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed without any issue noted and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was good.It was further reported that the 100% stenosed target lesion was located in a severely tortuous and severely calcified plantar artery.

• 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: 11138588
• MDR Text Key: 225754704
• Report Number: 2134265-2021-00089
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767220
• UDI-Public: 08714729767220
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0023223916
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1