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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  Malfunction  
Event Description

It was reported that balloon rupture occurred. The 100% stenosed target lesion was located in severe tortuous and severely calcified below the knee. A 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation of a critical limb ischemia. However during first inflation at 8 atmospheres for 5 seconds the balloon ruptured. The procedure was completed with the another of the same device. No patients complications.

 
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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 Key9481402
MDR Text Key176636846
Report Number2134265-2019-15852
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 02/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
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 Number0023787204
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/14/2019
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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