MAUDE Adverse Event Report: ST PAUL PORTEX; EPIDURAL

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.

• Brand Name: PORTEX
• Type of Device: EPIDURAL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11614426
• MDR Text Key: 243782585
• Report Number: 3012307300-2021-02836
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: 21-1500-01
• Device Lot Number: 1882782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 52