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

Model Number	11823
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient tracking received a tracking form through email reporting a catheter revision due to catheter migration.The patient was reported to have a lack of pain relief and had volume discrepancies observed at their last four refill appointments.A catheter dye study was performed and it was determined that the catheter was shown to be pulled out of the intrathecal space.The patient had reported a previous fall, but could not recall when it was.The patient's old catheter was discarded after the 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 sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit.Device was discarded and was not returned for additional evaluation and investigation.As additional investigation was not performed, a definitive root cause for the alleged issue could not be determined.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 ; 9734269229
• MDR Report Key: 17954040
• Report Number: 3010079947-2023-00064
• Device Sequence Number: 6620954
• Product Code: LKK
• UDI-Device Identifier: 00810335020099
• UDI-Public: (01)00810335020099(17)230524(10)27949
• 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: 2021
• 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): 10/17/2023

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: 05/24/2023
• Device Model Number: 11823
• Device Catalogue Number: 11823
• Device Lot Number: 27949
• 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: Not provided
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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