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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 08/22/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.A 2mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the target lesion was located in the superficial femoral artery.The balloon ruptured during first inflation at 10 atmospheres.There was no segment of the balloon left inside the patient after it ruptured.
 
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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 Key8949854
MDR Text Key156114079
Report Number2134265-2019-10417
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767190
UDI-Public08714729767190
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 09/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2021
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0023019537
Was Device Available for Evaluation? No
Date Manufacturer Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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