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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 24706
Medical Device Problem Code Entrapment of Device (1212)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that catheter entrapment on guidewire occurred.A 2.5mm x 220mm x 150cm coyote balloon catheter was advanced for use.However, it was noted that the balloon was stuck on the wire.Both wire and balloon catheter were removed from the patient together at the same time.The procedure was completed with another of the same device.No patient complications nor injuries reported.
 
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Brand Name
COYOTE
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11436520
Report Number2134265-2021-02089
Device Sequence Number17098358
Product Code DQY
UDI-Device Identifier08714729796718
UDI-Public08714729796718
Combination Product (Y/N)N
Initial Reporter StateDE
Initial Reporter CountryUS
PMA/510(K) Number
K111295
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/23/2023
Device Model Number24706
Device Catalogue Number24706
Device Lot Number0026562055
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/12/2021
Initial Report FDA Received Date03/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDE WIRE: TERUMO GLIDEADVATANGE
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