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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 Problems Material Rupture (1546); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2019
Event Type  Malfunction  
Event Description

It was reported that balloon rupture occurred the 100% stenosed target lesion was located in the moderately tortuous and severely calcified below the knee. A 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation. However, during third inflation at 8 atmospheres, the balloon ruptured. The procedure was completed with another device. There were no patient complications reported.

 
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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 Key9410524
MDR Text Key175082184
Report Number2134265-2019-14908
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2019
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 Number0023485730
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/03/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2019
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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