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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 24698
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/19/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 2.5mm x 150mm x 150cm coyote balloon catheter was advanced for dilation.However, during the second inflation at 14 atmospheres for 1 minute, the balloon ruptured.The procedure was completed with another of the same device.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 Key12240357
Report Number2134265-2021-09728
Device Sequence Number19858868
Product Code LIT
UDI-Device Identifier08714729796886
UDI-Public08714729796886
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K111295
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/28/2021
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 Date08/28/2022
Device Model Number24698
Device Catalogue Number24698
Device Lot Number0024345685
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/19/2021
Initial Report FDA Received Date07/28/2021
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: JUPITER FC; INFLATION DEVICE: PS25; INTRODUCER SHEATH: DESTINATION 6FR
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