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

Model Number	11830
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported a pump malfunction that had occurred "about one month ago." patient reported that they began to experience an increase in pain and withdrawal symptoms.They went to the emergency room and reportedly suffered a "myocardial infarction".The patient reports their pump managing physician did a dye study and a "scan that showed the valves" as a result of this incident.The patient was unable to provide the result of the scan.The patient reported that "the dye study was inconclusive" and stated that the doctor felt it was "more difficult than usual to push the dye through the catheter".The patient's pump was reportedly empty and off at the time of the report.The patient reports that they did not experience any falls, accidents, or mri's prior to this incident.The patient referenced a statement that "was made by the fda that states cpap machines should not be used by those with implanted pumps." the patient inquired if the cpap machine could have affected their pump to which technical support advised that the events appeared to be related to the patient's catheter.Per follow-up with the physician's office, the receptionist reported that an underinfusion volume discrepancy was noted.The patient reported symptoms of withdrawal, and an additional underinfusion volume discrepancy was observed a week after the first.A day later, a dye study was performed and the notes from this appointment state that "the catheter was cleared at the dye study".The pump was then drained, turned off, and the patient was prescribed orals.The physician reportedly wanted to stabilize the patient before deciding how to proceed with the pump.The appointment notes also noted that philips had contacted this patient to make them aware of the urgent medical device correction for their cpap machine.No further information was provided.
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter revision kit, verification of all final testing performed by/on the us catheter revision kit, and packaging for subject us catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter revision kit function.Device remains implanted and was not returned for additional evaluation and investigation.As additional physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.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
• 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: 15807258
• Report Number: 3010079947-2022-00198
• Device Sequence Number: 5747682
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)201110(10)24869
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 11/10/2020
• Device Model Number: 11830
• Device Catalogue Number: 11830
• Device Lot Number: 24869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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: Hospitalization
• Patient Sex: Female