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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 Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that balloon rupture occurred. A 5. 0mmx150mmx150cm (4f) sterling balloon catheter was used for dilation. However, during first inflation under nominal pressure at 30 seconds, the balloon ruptured. The procedure was completed with another of the same device. There were no patient complications 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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9437032
MDR Text Key176026507
Report Number2134265-2019-15194
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/11/2019
Device MODEL Number24690
Device Catalogue Number24690
Device LOT Number0022248828
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/14/2018
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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