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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 11/05/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in non-tortuous and heavily calcified anterior tibial artery.A 3.0mm x 220mm x 150cm coyote balloon catheter was advanced for dilatation.However, during first inflation, the balloon ruptured at nominal pressure.The device was removed and the procedure was completed with a different device.No complications 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 Key10883523
Report Number2134265-2020-16247
Device Sequence Number16895381
Product Code DQY
UDI-Device Identifier08714729797265
UDI-Public08714729797265
Combination Product (Y/N)N
Initial Reporter StateMI
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) 11/23/2020
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 Date10/02/2023
Device Model Number24706
Device Catalogue Number24706
Device Lot Number0026117691
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/05/2020
Initial Report FDA Received Date11/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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