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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA INTRATHECAL CATHETER IMPLANTABLE INTRATHECAL CATHETER

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FLOWONIX MEDICAL, INC. PROMETRA INTRATHECAL CATHETER IMPLANTABLE INTRATHECAL CATHETER Back to Search Results
Model Number 11823
Device Problems Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 04/07/2016
Event Type  Injury  
Manufacturer Narrative
Internal complaint number: (b)(4). Mfr 3010079947-2018-00040 is related to mfr 3010079947-2018-00039.
 
Event Description
It was reported that the intrathecal pump was observed loose and the catheter was kinked. Surgical intervention was taken to revise the pump pocket and unkink the catheter.
 
Manufacturer Narrative
(b)(4). Mfr 3010079947-2018-00039 is related to mfr 3010079947-2018-00040.
 
Event Description
On (b)(6) 2018, a healthcare professional reported the physician determined that the pump was highly mobile and was likely to kink the catheter. Therefore, the pump pocket was revised. The catheter was not kinked as initially reported.
 
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Brand NamePROMETRA INTRATHECAL CATHETER
Type of DeviceIMPLANTABLE INTRATHECAL CATHETER
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive NJ 07828
Manufacturer Contact
karen matis
500 international drive
suite 200
mount olive, NJ 07828
9734269229
MDR Report Key7304541
MDR Text Key101236206
Report Number3010079947-2018-00039
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/07/2017
Device Model Number11823
Device Catalogue Number11823
Device Lot Number20725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/28/2018 Patient Sequence Number: 1
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