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

Model Number 11823

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Pending completion of device analysis.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.Internal complaint number: (b)(4).

Event Description

Sales representative contacted technical solutions in order to report a catheter with a potential leak.Representative stated that the physician was conducting a dye study to assess for catheter patency and found that the dye was pooling "behind the pump".Patient underwent catheter revision surgery, in which a hole was observed in the catheter.The catheter was removed below where the hole was and the doctor attempted to inject through the segment to determine patency.The remaining catheter was not patent.Sales representative stated that multiple slimy, brittle strands were coming out of the catheter.Entire catheter was later explanted and replaced.

Manufacturer Narrative

Five sections of the catheter were returned and evaluated.A visual inspection of the catheter verified the catheter had been cut or severed, confirming the complaint.The second section of the catheter had a confirmed slice located at the half way point, and the slice appears to have been made with a sharp instrument.An attempt by engineering to reproduce the slice verified it most likely was cut with a sharp instrument in one swift slice rather than with a sawing motion.Upon analysis, the alleged occlusions appeared to be due to dried biological material (blood) located within the catheter.The time between explant and device return (approximately three weeks) was an adequate amount of time for the biological material to dry and harden in the catheter.This may not have been the original cause for the occlusion observed in the complaint, but it is the current cause.The root cause for the alleged occlusion observed in the complaint could not be determined.Internal complaint number: (b)(4).

• Brand Name: INTRATHECAL CATHETER
• Type of Device: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 10658989
• MDR Text Key: 210710589
• Report Number: 3010079947-2020-00312
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)211203(10)26087
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2021
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 26087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention