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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2019
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : the device was returned for analysis. The shaft, tip, and balloon were microscopically and visually examined. There was blood in the inflation lumen, guidewire lumen, and in the balloon. The balloon was loosely folded. There were numerous kinks throughout the hypotube. The balloon had a pinhole at the proximal edge of the markerband with a scratch over the markerband. The tip was damaged.

 
Event Description

Reportable based on device analysis completed on 02-dec-2019. This device was received with no reported issues. However, upon review of this device, a pinhole was found in the balloon.

 
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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 Key9437124
MDR Text Key175882557
Report Number2134265-2019-15161
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial
Report Date 12/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2019
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 Number0024074488
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/09/2019
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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