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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 Difficult to Remove ; Failure to Advance; Detachment of Device or device Component
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that the balloon became stuck and the distal tip detached when removed. Vascular access was obtained via ipsilateral antegrade approached. The 99% stenosed target lesion was in a severely tortuous and severely calcified right plantar artery. A 1. 5mmx20mmx143cm coyote balloon catheter and a 6f guidezilla ii pv long guide extension catheter were used for treatment. During procedure, the balloon was unable to pass through the guidezilla ii and inflation was performed once at that position. When the balloon was tried to remove after inflation, it was noted to be stuck and the distal tip of the balloon became separated/detached. The detached balloon was retrieved using another method. No further patient complications were 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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9412155
Report Number2134265-2019-14933
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24691
Device Catalogue Number24691
Device LOT Number0024074488
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/09/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/04/2019 Patient Sequence Number: 1
Treatment
GUIDEWIRE- JUPITER FC 300
GUIDEZILLA II GUIDE EXTENSION CATHETER
INTRODUCER SHEATH- 4.5 PARENT
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