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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 24716
Device Problem Material Puncture / Hole
Event Date 04/02/2019
Event Type  Malfunction  
Event Description

It was reported that shaft perforation occurred. The target lesion was located in the left superficial femoral artery. After insertion of a non-bsc guide wire, a 4. 0x220x90 (4f) sterling balloon catheter was advanced for dilation. However, during imaging, the wire appeared to be coming out of the device. The device was removed and was inflated outside of the patient. It was then noted that the catheter had three holes. The procedure was completed with another of the same device. No patient complications were reported and patient status was stable.

 
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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
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8545118
Report Number2134265-2019-04253
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 06/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24716
Device Catalogue Number24716
Device LOT Number0022227531
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/08/2018
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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