Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device and no patient complications were reported.
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr.:returned product consisted of a coyote es balloon catheter.There was contrast in inflation lumen and balloon.There were numerous kinks throughout the device.The balloon was loosely folded.Microscopic inspection of the device did not reveal any holes or damage to the balloon.Functional testing was performed using a water filled inflation device.The inflation device was connected to the hub of the catheter and pressurized for 5 minutes to 14 atm.There were no leaks observed and the device remained inflated.
 
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The procedure was completed with another of the same device and no patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COYOTE ES
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9384787
MDR Text Key173947503
Report Number2134265-2019-14415
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767169
UDI-Public08714729767169
Combination Product (y/n)N
PMA/PMN Number
K093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
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 Number0023708259
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-