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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 24701
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during the third inflation at 10 atmospheres, the balloon ruptured.The balloon was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the anterior tibial artery.A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation.However, during the third inflation at 10 atmospheres, the balloon ruptured.The balloon was removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of a coyote es balloon catheter.The balloon was loosely folded, and the device was bloody.Analysis of the tip, balloon, markerbands, inner/outer shaft and hypotube included microscopic and visual inspection.Inspection revealed a burst in the balloon material that was 9mm in length.Inspection of the rest of the rest of the device found no other damage or defect.
 
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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 Key9339109
MDR Text Key168799608
Report Number2134265-2019-14009
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729767411
UDI-Public08714729767411
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,health
Type of Report Initial,Followup
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/05/2021
Device Model Number24701
Device Catalogue Number24701
Device Lot Number0023442394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age83 YR
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