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

Model Number 24701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 10/22/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain and underwent surgery.The target lesion was located in a vessel in the right lower extremity.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation and the procedure was completed.After 1.5 months, the patient returned experiencing pain behind the knee.Ultrasound revealed that a foreign material was causing the pain.It was determined that during preparation of the initial procedure, the balloon protective covering was accidentally left on the balloon.Upon balloon inflation, the plastic protective covering was left inside of the patient and the balloon itself was removed.The patient underwent an endarterectomy to remove the balloon protective sleeve.No other patient complications were reported.

Manufacturer Narrative

Age at time of event: 18 years or above.

• 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 SCIMED, INC
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13500243
• MDR Text Key: 285358955
• Report Number: 2134265-2022-01088
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention