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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 10/12/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older.

 
Event Description

Reportable based on device analysis complete on 09 nov 2018. It was reported that crossing difficulties were encountered. The stenosed target lesion was located in the below the knee (btk). An unknown guidewire was advanced to the target lesion and pre-dilated with 2. 5mm x 40mm x 146cm coyote es balloon catheter with a combination of an unknown guidezilla 2 pv guide extension catheter as a back up to strengthen the balloon but still failed to cross the lesion. The procedure was completed with a non bsc product. No patient serious injury or adverse event were reported. However, returned device analysis revealed balloon pinhole. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. The inner shaft is buckled in numerous locations. Microscopic examination revealed that the balloon has a pinhole at the distal markerband. Inspection of the remainder of the device presented no other damage or irregularities.

 
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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 Key8126712
Report Number2134265-2018-63484
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2018
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 Number0021973783
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/30/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/10/2018
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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