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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 Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, during fourth inflation at 8 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 2mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, during fourth inflation at 8 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 18.9cm distal from the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 5mm long starting 2mm from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
 
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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 Key9353548
MDR Text Key173461649
Report Number2134265-2019-14189
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767176
UDI-Public08714729767176
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 01/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/18/2022
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0024285673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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