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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 24690
Device Problems Failure to Advance; Adverse Event Without Identified Device or Use Problem
Event Date 08/20/2018
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event 18 years or older.

 
Event Description

Reportable based on device analysis completed on 17sep2018. It was reported that crossing difficulties were encountered. The 100% stenosed target lesion was located in a moderately calcified and moderately tortuous vein side shunt. A 5. 0mmx220mmx150cm (4f) sterling balloon catheter was advanced but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications were reported. However, returned device analysis revealed a longitudinal balloon tear.   returned product consisted of a sterling balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There was blood in the inflation lumen and balloon. The balloon was loosely folded. There were numerous kinks throughout the shaft. There was a 4cm longitudinal balloon tear at the proximal end of the balloon. Inspection of the device presented no other damage or irregularities. There was no evidence of any damage or irregularities contributing to the reported crossing difficulty, which could not be confirmed because the clinical circumstances could not be replicated.

 
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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 Key7956475
Report Number2134265-2018-61852
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 10/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/11/2019
Device MODEL Number24690
Device Catalogue Number24690
Device LOT Number22123441
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/05/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2018
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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