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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 12/04/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr. : returned product consisted of a coyote es balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. The tip is damaged. Microscopic examination revealed that the balloon has a 10mm longitudinal tear starting at the proximal balloon cone. Inspection of the remainder of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on 18jan2019. It was reported crossing difficulties were encountered. The target lesion was located in a vessel below the knee. After crossing a guide wire, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced for pre-dilatation but the device failed to cross the lesion. The procedure was completed with a non-bsc device. No patient complications were reported. However, returned device analysis revealed a longitudinal balloon tear.

 
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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 Key8331093
Report Number2134265-2019-01124
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 02/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2019
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 Number0022104005
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 Received01/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2018
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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