• 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 24691
Device Problem Failure to Advance
Event Date 02/06/2019
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product. Device evaluated by mfr: the device was returned for analysis. The balloon is loosely folded with blood in the inflation lumen and balloon. The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined. There are numerous hypotube and shaft kinks. Microscopic examination of the device presented that a portion of the outer shaft was plastically deformed 9. 8cm from the tip which also has a 2mm longitudinal tear. The balloon is intact and has no damage. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The inner shaft is buckled in numerous locations. The tip is damaged. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any damage or irregularities contributing to the reported difficulty, which could not be confirmed because the clinical circumstances could not be replicated.

 
Event Description

Reportable based on device analysis completed on 17 mar 2019. It was reported that crossing difficulties were encountered. The target lesion was located in a vessel below the knee. A 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced but failed to cross the lesion. The procedure was completed with a different device. No patient serious injury nor adverse event were reported. However, returned device analysis revealed a shaft hole.

 
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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8465410
Report Number2134265-2019-03227
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
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 Number23056304
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-