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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 Failure to Advance
Event Date 12/20/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Returned product consisted of a coyote es balloon catheter. The balloon was loosely folded with blood in the inflation lumen and balloon. The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Microscopic examination of the device revealed that there is a 9mm longitudinal tear in the balloon starting 21mm from the proximal markerband. The tip is damaged. Inspection of the remainder of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on 08-feb-2019. It was reported that crossing difficulties were encountered. The target lesion was located in the vessel below the knee. A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation but failed to cross the lesion. The procedure was completed with a different device. No patient serious injury or adverse event were reported. However, returned device analysis revealed a longitudinal tear in the balloon material.

 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8387577
Report Number2134265-2019-01988
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2019
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 Number0022706970
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/14/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/26/2018
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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