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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 Material Rupture; Failure to Advance
Event Date 10/23/2019
Event Type  Malfunction  
Event Description

It was reported that balloon ruptures occurred. The 100% stenosed target lesion was located in a moderately tortuous and severely calcified subclavian artery. Several wires were introduced before one was finally able to cross the lesion. A 2mm x 20mm x 143cm coyote es balloon was advanced but was unable to cross the lesion. A 1. 5mm x 20mm x 143cm coyote es balloon was able to cross but during dilatation, on the first inflation at six atmospheres, the balloon ruptured. The 2mm x 20mm x 143cm coyote es balloon was introduced a second time but the balloon ruptured at about four atmospheres on the first inflation. A 2. 5mm x 20mm x 144cm coyote es was introduced and inflated once to six atmospheres and on the second inflation at six atmospheres this balloon also ruptured. Dilation was performed with a different balloon to complete the procedure. No 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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9292411
Report Number2134265-2019-13529
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2019
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 Number0023339185
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 Received10/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/13/2019
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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