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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24701
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/30/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(4).
 
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 3mm x 20mm x 143cm coyote es balloon catheter was advanced for dilation.However, on initial inflation at 14 atmospheres, the balloon ruptured.The device was removed without problem and the procedure was completed with a different device.There were no patient complications nor injuries reported.
 
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Brand Name
COYOTE ES
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10862160
Report Number2134265-2020-16051
Device Sequence Number2559316
Product Code LIT
UDI-Device Identifier08714729767398
UDI-Public08714729767398
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K093636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/18/2020
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 Date11/08/2020
Device Model Number24701
Device Catalogue Number24701
Device Lot Number0022915538
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/02/2020
Initial Report FDA Received Date11/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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