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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 24699
Device Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that froze on wire occurred. The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee vessel. A 3. 0mm x 220mm x 150cm coyote balloon catheter was advanced for dilation. However, the device became stuck with the guidewire and the shaft was kinked. The device was able to removed from and completed the procedure was completed with another of same device. The guidewire was able to be removed from the balloon catheter outside the patient. There were no patient complications reported.
 
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Brand NameCOYOTE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13933335
MDR Text Key288105335
Report Number2134265-2022-02844
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24699
Device Catalogue Number24699
Device Lot Number0028492518
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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