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 11/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.A 1.5mm x 20mm x 143cm coyote es balloon was advanced for dilation.However, during first inflation at 4 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that balloon rupture occurred.A 1.5mm x 20mm x 143cm coyote es balloon was advanced for dilation.However, during first inflation at 4 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
(b)(6).Returned product consisted of a coyote es balloon catheter.There was blood in the inflation lumen.Microscopic examination revealed a torn a length of 3mm on distal end of the balloon.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage revealed.The damage to the balloon is consistent with interaction with the lesion.There were numerous kinks throughout the catheter.
 
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 Key9447321
MDR Text Key176225998
Report Number2134265-2019-15419
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 01/21/2020
1 Device was Involved in the Event
1 Patient was 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 Date01/13/2022
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0023181030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Date Manufacturer Received01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-