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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
It was reported that the patient experienced pain and underwent surgery. The target lesion was located in a vessel in the right lower extremity. A 3mm x 40mm x 145cm coyote es balloon catheter was advanced for dilatation and the procedure was completed. After 1. 5 months, the patient returned experiencing pain behind the knee. Ultrasound revealed that a foreign material was causing the pain. It was determined that during preparation of the initial procedure, the balloon protective covering was accidentally left on the balloon. Upon balloon inflation, the plastic protective covering was left inside of the patient and the balloon itself was removed. The patient underwent an endarterectomy to remove the balloon protective sleeve. No other patient complications were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or above.
 
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Brand NameCOYOTE ES
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13500243
MDR Text Key285358955
Report Number2134265-2022-01088
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number24701
Device Catalogue Number24701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/09/2022 Patient Sequence Number: 1
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