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

Model Number 24691

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred. A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation. However, during the initial inflation at 6 atmospheres for 5 seconds, the balloon ruptured and a pinhole was noted. The device was replaced with a 2mm x 20mm x 143cm coyote es balloon catheter. However, during the initial inflation at 6 atmospheres for 5 seconds, the balloon also ruptured and a pinhole was noted. The device was removed and the procedure was completed with a different device. There were no patient complications reported and the patient was in good condition after the procedure.

• Brand Name: COYOTE ES
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14256010
• MDR Text Key: 290442269
• Report Number: 2134265-2022-05015
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0027996206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial