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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 12/05/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr: the balloon was loosely folded with blood in the balloon. There are numerous hypotube and shaft kinks. The tip is damaged. Microscopic examination revealed that the balloon has a pinhole at the markerband. Inspection of the remainder of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on  22-jan-2019. It was reported that crossing difficulties were encountered. During a stenosis treatment procedure below the knee, a 1. 5mm x 20mm x 143cm coyote balloon catheter was advanced for dilation. However, the device could not cros the lesion. The procedure was completed with a different device. There were no patient complications nor injuries were reported. However, returned device analysis revealed a balloon pin 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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8339336
Report Number2134265-2019-01289
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 02/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2019
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 Number0022020612
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/21/2018
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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