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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24691
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Date of event: used the first day of the month of aware date as there was no date provided. Device evaluated by mfr. : returned product consisted of a coyote es balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There were numerous kinks. There was contrast and blood in the inflation lumen and balloon. The balloon was tightly folded. The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device. The inner shaft was buckled 70mm from the tip. There was a hole in the inner shaft in the buckled area, and a hole in the outer shaft at 74mm from the tip. The hole was consistent with an interaction with a guidewire. Inspection of the remainder of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on 24mar2020. It was reported that tracking difficulties were encountered. A 2mm x 40mm x 145cm coyote balloon catheter was selected for use. However, the device would not advance over the wire. The wire would not come though the monorail port. The procedure was completed with another of the same device. No patient complications were reported. However, returned device analysis revealed an outer shaft hole.

 
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Brand NameCOYOTE ES
Type of DeviceCATHETER, 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 Key9967465
MDR Text Key187877939
Report Number2134265-2020-04368
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 04/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24691
Device Catalogue Number24691
Device LOT Number0024628589
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/21/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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