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

Model Number	11830
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Confusion/ Disorientation (2553); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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-conformances, issues or capas associated with catheter revision kit function.Device was not returned for additional evaluation and investigation.Nurse practitioner was unable to access the records regarding the reason for cap study.As device was not returned, a definitive root cause could not be determined for the alleged issue.Patient symptoms have reportedly resolved.A supplemental mdr will be submitted if further information is obtained.Internal complaint number: (b)(4).
Event or Problem Description
Clinical specialist (cs) reported that a patient felt confusion following patient therapy controller doses after pump refills.Patient reportedly has an older medtronic catheter connected to a flowonix catheter which connects to the pump.Per follow-up, nurse practioner reported a catheter dye study was performed two years ago in which the catheter could not be aspirated.It was believed the possible issue could be kinking of the catheter, but the exact reason for cap study could not be confirmed.Patient is currently doing well with no further issues reported.
Additional Manufacturer Narrative
Device was returned for additional evaluation and investigation.There was a section of catheter that totaled 4.25 inches long, that was comprised of two smaller sections of catheter joined together by a barb.The 1 inch section was not a flowonix catheter, but was patent with air and sterile water.The other section was 3.25 inches long and also found to be patent with air and sterile water.The barb used to attach the two sections was found to be occluded.Per the instructions for use of the device, occlusions are known possible risks of use of the device.Internal complaint number: (b)(4).
Event or Problem Description
It was confirmed that the patient's catheter was explanted along with the patient's pump.Mfr 3010079947-2021-00324 was opened to address the pump explant.

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: INTRATHECAL CATHETER
• Manufacturer (Section D): FLOWONIX MEDICAL, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): FLOWONIX MEDICAL, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: james bennett ; 500 international drive; suite 200; mount olive, NJ 07828 ; 9734269229
• MDR Report Key: 12110112
• Report Number: 3010079947-2021-00185
• Device Sequence Number: 3800331
• 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
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male