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

Model Number 24691

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  Injury  

Event Description

It was reported that balloon detachment and removal difficulty encountered.The 99% stenosed target lesion was located in the severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, the balloon could not be removed and when pulled out with a strong force, the balloon was separated at the joint of the monorail.The detached fragment was successfully recovered from the patient's body.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

B1: adverse event/product problem corrected from product problem to adverse event and product problem.H1: type of reportable event corrected from malfunction to serious injury.

Event Description

It was reported that balloon detachment and removal difficulty encountered.The 99% stenosed target lesion was located in the severely calcified vessel below the knee.A 2.5mm x 40mm x 146cm coyote es balloon catheter was advanced for dilatation.However, the balloon could not be removed and when pulled out with a strong force, the balloon was separated at the joint of the monorail.The detached fragment was successfully recovered from the patient's body.The procedure was completed with a different device.No patient complications were reported.It was further reported that the physician snared the detached fragment.

• 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: 11124391
• MDR Text Key: 225331079
• Report Number: 2134265-2020-18458
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 24691
• Device Catalogue Number: 24691
• Device Lot Number: 0025947641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention