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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 Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/28/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous and severely calcified left superficial femoral artery.A 2.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during the second inflation at nominal pressure, the balloon ruptured.The device was completely removed by pulling negative pressure and withdrew normally.The procedure was completed with another of the same device.No patient complications nor injuries were 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 Key9703406
Report Number2134265-2020-01464
Device Sequence Number11474264
Product Code DQY
UDI-Device Identifier08714729796466
UDI-Public08714729796466
Combination Product (Y/N)N
Initial Reporter StateOR
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 Other
Type of Report Initial
Report Date (Section B) 02/12/2020
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 Date12/02/2022
Device Model Number24706
Device Catalogue Number24706
Device Lot Number0024862417
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2020
Initial Report FDA Received Date02/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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