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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24700
Device Problems Difficult to Flush (1251); Defective Device (2588)
Patient Problem Pain (1994)
Event Date 06/04/2019
Event Type  Injury  
Event Description

It was reported the balloon inflated unintentionally and the patient experienced pain. A 4. 0mmx40mmx40cm (4f) sterling balloon catheter was used during the procedure. At the time of flushing, contrast was being injected and resistance was already felt. Upon performing angiography from the guide wire lumen, the balloon inflated itself and the patient complained of pain at the point of inflation. The device was simply removed and the procedure was completed with a different device. No further patient complications were reported and the patient's current condition is good.

 
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Brand NameSTERLING
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8757541
MDR Text Key149924130
Report Number2134265-2019-06713
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2020
Device MODEL Number24700
Device Catalogue Number24700
Device LOT Number0020234747
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/02/2017
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: 07/03/2019 Patient Sequence Number: 1
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