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

Model Number 24691

Device Problems Material Rupture (1546); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred the 100% stenosed target lesion was located in the moderately tortuous and severely calcified below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, during third inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with another device.There were no patient complications reported.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, during third inflation at 8 atmospheres, the balloon ruptured.The procedure was completed with another device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.There were numerous kinks throughout the catheter.Microscopic inspection revealed a tear over the markerband.The torn material was pulled up which indicates that the balloon became caught on either calcification or another device during withdrawal.The reported balloon rupture was confirmed.

• 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: 9410524
• MDR Text Key: 175082184
• Report Number: 2134265-2019-14908
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767169
• UDI-Public: 08714729767169
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0023485730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1