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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 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 99% 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 inflation the balloon ruptured.The device was completely removed without any issues.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).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 were numerous kinks.There was contrast and blood in the inflation lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a circumferential tear 2mm long at the distal marker band, and another circumferential tear at the proximal marker band.There was no marker band damage detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.
 
Event Description
It was reported that balloon rupture occurred.The 99% 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 inflation the balloon ruptured.The device was completely removed without any issues.The procedure was completed with a different device.There were no patient complications nor injuries reported.
 
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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 Key10102494
MDR Text Key193128704
Report Number2134265-2020-07233
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 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2022
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0024935906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2020
Date Manufacturer Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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