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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 Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2020
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2020 was used since event date was not provided.

 
Event Description

It was reported that unsealed device packing was encountered. A 6. 0mmx80mmx135cm sterling balloon catheter was selected for use. However, it was noted that the balloon package was not completely sealed. The procedure was completed with a different device. No patient complications were reported.

 
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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
MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10174759
MDR Text Key195761095
Report Number2134265-2020-08249
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24700
Device Catalogue Number24700
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
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

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