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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24696
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 2.0mm x 80mm x 150cm, mr coyote balloon catheter was advanced for dilatation.However, during the procedure, the device broke where the balloon met the shaft.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Returned product consisted of a coyote balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported separation.
 
Event Description
It was reported that shaft break occurred.A 2.0mm x 80mm x 150cm, mr coyote balloon catheter was advanced for dilatation.However, during the procedure, the device broke where the balloon met the shaft.The procedure was completed with a different device.No patient complications were reported.
 
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Brand Name
COYOTE
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12986523
MDR Text Key282200573
Report Number2134265-2021-15514
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729796169
UDI-Public08714729796169
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24696
Device Catalogue Number24696
Device Lot Number0027711266
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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