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

Model Number 24701

Device Problem Entrapment of Device (1212)

Patient Problem Pain (1994)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

It was reported that catheter and guidewire entrapment, pain and aborted procedure occurred. The 100% stenosed target lesion was located in the mildly calcified distal superficial femoral artery. A 3. 5mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation. The balloon was deployed; however, during withdrawal, the physician could not remove the balloon over the choice guidewire. The balloon and the wire were entirely removed as one unit. The physician decided to abort the procedure because the patient was having so much back pain. No patient complications were reported. The patient will return at a later date to be treated with atherectomy.

• 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: 11797607
• MDR Text Key: 249732091
• Report Number: 2134265-2021-05878
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/09/2022
• Device Model Number: 24701
• Device Catalogue Number: 24701
• Device Lot Number: 0025325247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial