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

Model Number	11823
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient tracking received a tracking form through email reporting a catheter replacement surgery.The reason for replacement was stated to be catheter migration with a loss of therapy.The catheter was discarded after surgery.
Additional Manufacturer Narrative
A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of all final testing performed by/on the catheter kit, verification of sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with the catheter kit.Device was discarded and was not returned.Per the instructions for use of the device, catheter migration is a known possible risk 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.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer (Section G): ALGORITHM SCIENCES, INC.; 120 forbes blvd; suite 170; mansfield MA 02048
• Manufacturer Contact: nicholas ranalli ; 120 forbes blvd; suite 170; mansfield, MA 02048 ; 8459019335
• MDR Report Key: 17539874
• Report Number: 3010079947-2023-00058
• Device Sequence Number: 6303516
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)220724(10)26735
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2023

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: 07/24/2022
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 26735
• 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: 08/10/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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