MAUDE Adverse Event Report: ALGORITHM SCIENCES, INC. INTRATHECAL CATHETER

Model Number	11823
Medical Device Problem Codes	Fracture (1260); Obstruction of Flow (2423)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/30/2023
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 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.Device remains implanted and was not returned for additional evaluation and investigation.As physical investigation was not performed on the device, a definitive root cause could not be determined for the alleged issue.Several attempts have been made to inquire about patient status and the potential replacement surgery, but additional information has not been confirmed at this time.If additional information becomes available, a supplemental mdr will be sent.Internal complaint number: (b)(4).
Event or Problem Description
Agent contacted patient tracking by email to report that a patient had a dye study performed due to a lack of therapy.The physician was reportedly unable to aspirate.The agent reported that the plan was to replace the patient's catheter and pump.
Event or Problem Description
Agent covering the issue responded with additional information.Agent reported that the physician decided to replace the patient's pump due to the pump's age.The physician also decided to replace the patient's catheter as it was severed above the anchor position.Agent reported that a new pump and catheter were implanted and the patient is now receiving therapy.The patient's old pump and catheter were discarded.
Additional Manufacturer Narrative
As the devices were confirmed to be discarded, no additional investigation could be performed.As no investigation was performed, a definitive root cause could not be determined for the alleged issue.Per the instructions for use of the device, catheter tears/breaks are known possible risks of use of the device.Internal complaint number: (b)(4).

• Brand Name: INTRATHECAL CATHETER
• Common Device Name: INTRATHECAL CATHETER
• Manufacturer (Section D): ALGORITHM SCIENCES, INC.; 500 international drive; suite 200; mount olive NJ 07828
• Manufacturer (Section G): ALGORITHM SCIENCES, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: nicholas ranalli ; 500 international drive; suite 200; mount olive, NJ 07828 ; 8459019335
• MDR Report Key: 17225709
• Report Number: 3010079947-2023-00048
• Device Sequence Number: 7177221
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)170516(10)20898
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P080012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 05/30/2023

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: 05/16/2017
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 20898
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2015
• 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: Female