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

Model Number	11830
Medical Device Problem Codes	Fracture (1260); Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending additional follow up regarding causality of issue.A review of the device history record, which includes verification of all steps in the manufacturing of the catheter revision kit, verification of all final testing performed by/on the catheter revision kit, verification of sterilization, and packaging for subject catheter revision kit was performed.The review did not identify any non-conformance's, issues or capas associated with catheter revision kit function.Device was discarded and not returned for additional evaluation and investigation.Per the instructions for use of the device, catheter migration, kinking and fracturing are all known possible risks of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) contacted technical solutions to report a catheter revision.Initially, the patient was seen for a refill appointment where they reported unrelieved pain.An underinfusion volume discrepancy was observed with the expected volume being 0.0ml and the actual aspirated volume was 18.4ml.Days later, a catheter dye study was performed during which the physician was unable to aspirate csf.It was observed that the catheter tip had migrated out of the intrathecal space and had kinked.The patient's catheter was later revised.During the revision surgery, a catheter fracture was observed.The removed catheter portion was discarded.During the surgery, the patient's pump was reanchored as well.Please note that mfr 3010079947-2021-00237 will capture the pump revision.
Additional Manufacturer Narrative
Clinical specialist (cs) reported that the cause of the catheter migration is unknown.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• MDR Report Key: 12302919
• Report Number: 3010079947-2021-00232
• Device Sequence Number: 14468793
• Product Code: LKK
• UDI-Device Identifier: 00810335020105
• UDI-Public: (01)00810335020105(17)171015(10)21250
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2017
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 21250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention