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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 (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Device evaluated by mfr. : the returned product consisted of a coyote es balloon catheter. Visual and microscopic inspection of the device revealed a tear in the balloon on the proximal end and the tip was damaged.

 
Event Description

Reportable based on device analysis completed on 20-nov-2020. It was reported that crossing difficulty was encountered. The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee. A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation but failed to cross the lesion. The procedure was completed with a different device and no patient complications were reported. However, returned device analysis revealed a tear 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 Key10971756
MDR Text Key220456720
Report Number2134265-2020-17206
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
Report Date 12/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2020
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 Number0024935906
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/16/2019
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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