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 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a below the knee artery.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.However, during inflation at 8 atmospheres with an inflation time of 45 seconds, the balloon ruptured occurred.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a below the knee artery.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilation.However, during inflation at 8 atmospheres with an inflation time of 45 seconds, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

(b)(6).Returned product consisted of a coyote es balloon catheter.There was blood in the inflation lumen and balloon.The hypotube had numerous kinks.Microscopic examination revealed a pinhole over the proximal markerband.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.The damage to the balloon is consistent with interaction with the lesion.

• 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: 9455658
• MDR Text Key: 176228669
• Report Number: 2134265-2019-15619
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: 08714729767190
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0023584665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1