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

Model Number 11823

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Catheter is not available for return and believed cause of the pin hole leak was not known.Pending dhr review.Internal complaint number: (b)(4).

Event Description

Clinical specialist (cs) reported a patient's pump was reanchored due to "it was sticking out more" (captured in related mfr 3010079947-2020-00284).According to the cs, "during the procedure there was clear fluid consistent with csf in the pocket.When the catheter was inspected there was a pinhole defect seen with leak of clear fluid consistent with csf.".

Manufacturer Narrative

A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.As the device wasn't returned for additional evaluation or investigation, and the clinical specialist did not have any additional information to suggest causality, no root cause was able to be determined for the damage alleged to the catheter.Internal complaint number: (b)(4).

• Brand Name: PROMETRA INTRATHECAL CATHETER KIT
• Type of Device: IMPLANTABLE INTRATHECAL CATHETER KIT
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive, nj
• MDR Report Key: 10484054
• MDR Text Key: 205338800
• Report Number: 3010079947-2020-00282
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2018
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 21576
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention