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

Model Number 24691

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  Malfunction  

Manufacturer Narrative

(b)(6). Device evaluated by mfr. : the returned product consisted of a coyote es balloon catheter. Visual and microscopic inspection of the device revealed a tear in the balloon on the proximal end and the tip was damaged.

Event Description

Reportable based on device analysis completed on 20-nov-2020. It was reported that crossing difficulty was encountered. The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee. A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation but failed to cross the lesion. The procedure was completed with a different device and no patient complications were reported. However, returned device analysis revealed a tear 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: 10971756
• MDR Text Key: 220456720
• Report Number: 2134265-2020-17206
• Device Sequence Number: 1
• Product Code: LIT
• 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: COMPANY REPRESENTATIVE,DISTRI

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/08/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/08/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 24691
• Device Catalogue Number: 24691
• Device LOT Number: 0024935906
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 12/16/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial