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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 Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/25/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via brachial artery.The 60% stenosed, 50 x 9.62mm, concentric, de novo target lesion was located in a mildly tortuous and non-calcified brachiocephalic vein.A 2.5mm x 80mm x 150mm coyote balloon catheter was advanced for dilatation.However, upon initial inflation at 12 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
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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 Key8515609
Report Number2134265-2019-03884
Device Sequence Number2758927
Product Code DQY
UDI-Device Identifier08714729797180
UDI-Public08714729797180
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K111295
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) 04/15/2019
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 Date05/24/2020
Device Model Number24704
Device Catalogue Number24704
Device Lot Number0020689970
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/25/2019
Initial Report FDA Received Date04/15/2019
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 CATHETER: 7F SHEATH; GUIDE WIRE: AMPLATZ WIRE 0.0035
Patient Age51 YR
Patient Weight57
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