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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 24704
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/20/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a vessel in a lower extremity.A 2.0mm x 80mm x 150cm coyote balloon catheter was selected for use.However, the device could not be tracked over wire as the shaft was cracked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
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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 Key7970514
Report Number2134265-2018-61882
Device Sequence Number1682132
Product Code DQY
UDI-Device Identifier08714729796428
UDI-Public08714729796428
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K111295
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/16/2018
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 Date02/26/2021
Device Model Number24704
Device Catalogue Number24704
Device Lot Number0021793569
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2018
Initial Report FDA Received Date10/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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