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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 24705
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained by ipsilateral approach via the femoral artery.The 99% stenosed target lesion was located in the moderately calcified left superficial femoral artery - below the knee.After crossing the guidewire, a 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.The balloon was initially inflated at nominal pressure; however, on the second inflation at about 10 atmospheres, the balloon ruptured.The procedure was completed with another same size coyote balloon catheter.There were no patient complications nor injuries 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 Key10237853
Report Number2134265-2020-08984
Device Sequence Number11370698
Product Code DQY
UDI-Device Identifier08714729796534
UDI-Public08714729796534
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 07/06/2020
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 Date12/04/2022
Device Model Number24705
Device Catalogue Number24705
Device Lot Number0024877288
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/02/2020
Initial Report FDA Received Date07/06/2020
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
GUIDEWIRE: NEO'S VARIOUS TYPES; INTRODUCER SHEATH: PARENT 4.5FR
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