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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL PORTEX; EPIDURAL

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ST PAUL PORTEX; EPIDURAL Back to Search Results
Catalog Number 21-1500-01
Device Problem Separation Failure (2547)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/16/2020
Event Type  Injury  
Event Description
Reported implantable ports|deltec specialty epidural ports described and event of idursulfase being infused intrathecal for eight years when failure occurred.This medication was being given for therapy to a (b)(6) year old male diagnosed with huntington syndrome along with epilepsy since (b)(6) 2018.The event described failure of the intrathecal catheter being dislodged from the reservoir proximal and uncertain position distally.Then described intervention of abdominal xray was taken along with other testing of cfs fluid.Chest x ray was describing the tip at approximately the level of t -2 spine of the thoracic level.Then on (b)(6) 2021 the issue of device failure was reported to be resolved.Product may have caused or contributed to serious injury.No additional adverse patient effects.Device revealed it had expired when it was in usage.
 
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Brand Name
PORTEX
Type of Device
EPIDURAL
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11614426
MDR Text Key243782585
Report Number3012307300-2021-02836
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2015
Device Catalogue Number21-1500-01
Device Lot Number1882782
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received04/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age19 YR
Patient Weight52
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