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 12/15/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel below the knee.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient was good post procedure.

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel below the knee.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during the first inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported and the patient was good post procedure.

Manufacturer Narrative

Returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks to the hypotube and shaft.Microscopic examination revealed a pinhole 6mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.

• 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: 13118738
• MDR Text Key: 282978668
• Report Number: 2134265-2021-16338
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767190
• UDI-Public: 08714729767190
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2024
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0026814808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1