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 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 1.5mm x 20mm x 143cm coyote es balloon catheter.However, during inflation, the balloon ruptured.The procedure was completed with another of the same.No patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or older.Initial reporter city: (b)(6).

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 1.5mm x 20mm x 143cm coyote es balloon catheter.However,during inflation, the balloon ruptured.The procedure was completed with another of the same.No patient complciations were reported.It was further reported that the first balloon catheter ruptured during the first inflation at nominal pressure for 3 seconds; while the second balloon ruptured during the first inflation at nominal pressure for 10 seconds.Both devices were simply pulled out and completely removed.

• 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: 9453529
• MDR Text Key: 176231534
• Report Number: 2134265-2019-15454
• 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: 12/27/2019

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: 09/02/2022
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0024367659
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1