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

Model Number 24691

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 14 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and patient status was good.

Manufacturer Narrative

(b)(6).Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 34mm from the tip and is approximately 7mm long.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 14 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and patient status was good.

• 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: 11110188
• MDR Text Key: 224860126
• Report Number: 2134265-2020-18675
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729767220
• UDI-Public: 08714729767220
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0022776694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1