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

Model Number 11823

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/29/2021

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: complaint-(b)(4).

Event Description

Director of clinical engineering and applied technologies reported that a patient's pump and catheter was explanted.Physician informed the director of clinical engineering and applied technologies that the patient's catheter had spontaneously fractured at the point of intrathecal entry, l2-l3.The catheter was completely severed, and the intrathecal portion had further advanced into the intrathecal space, leaving this distal portion of the catheter unretrievable.The cause of this reported issue was determined to be unknown.No issues were reported with the pump.No patient effects were officially reported to flowonix concerning this patient.During the explant surgery, the physician removed the pump and the proximal portion of the catheter.The catheter body was cut once during the surgical removal and then cut again by the scrub tech while removing the fibrous tissue adhered to the catheter anchor.

Event Description

It was reported that the patient often complained of lack of therapy.

Manufacturer Narrative

Additional physical investigation was performed on the device, but the alleged issue could not be confirmed.Visual analysis concluded that a piece of the catheter may be missing due to none of the ends matching up.Of the two pieces that were returned, analysis confirmed that both sections were patent with air and swi.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
• 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: 12857411
• MDR Text Key: 285169270
• Report Number: 3010079947-2021-00321
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)200510(10)24344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2020
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 24344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female