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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 11/27/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during first inflation, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.Microscopic examination revealed that the hypotube had numerous kinks.A test inflation device was connected to the hub and pressurized inflating the device to rated burst pressure 14atm.The device maintained pressure for 5 minutes with no leaks or irregularities.
 
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during first inflation, the balloon ruptured.The device was removed and the procedure was completed with a different device.No patient complications nor injuries were 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 Key9419572
MDR Text Key175675652
Report Number2134265-2019-15117
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 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
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 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
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