• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24701
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device evaluated by mfr. :the device was returned for analysis. The shaft, hypotube, tip and balloon were microscopically and visually examined. There was contrast and blood in the inflation lumen and balloon. The balloon was loosely folded. There was a pinhole at the marker band. There was no marker band damage detected. Inspection of the remainder of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on 26-nov-2019. It was reported that balloon leak occurred. Vascular access was obtained via the right femoral artery. The 1. 5mmx80mm target lesion was located in the non-tortuous and non-calcified left brachial artery. A 1. 5mm x 20mm x 142cm coyote es balloon catheter was advanced for angioplasty. However, during inflation at nominal pressure, a balloon leak was noted via angiography. The device was removed and tested with leaks on both ends of the balloon. The procedure was completed with another of the same device. No patient complications were reported and patient status was stable. However, returned device analysis revealed balloon pinhole.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9446634
MDR Text Key176224254
Report Number2134265-2019-15357
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeMX
PMA/PMN NumberK093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/03/2021
Device MODEL Number24701
Device Catalogue Number24701
Device LOT Number0023287719
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/04/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-