MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000; IMPLANTED DRUG DELIVERY PUMP

Model Number	AP-03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Intera oncology received a report of a revision that was performed.The revision was due to the patient developing a pseudoaneurysm of her common hepatic artery and requiring a stent.The physician attached a tapered catheter to the already implanted hepatic artery infusion pump and inserted catheter into the splenic artery.No new pump was implanted.The physician reported everything went well.
Additional Manufacturer Narrative
The device history record was reviewed.The pump was manufactured on may 18, 2018.There were no nonconformances pertaining to this serial number.The device met all specifications prior to release from manufacturing.The expiration date was september 30, 2019.During communication with the physician, it was revealed that the cause for the revision was due to the patient developing a pseudoaneurysm of her common hepatic artery and requiring a stent.The surgical procedure consisted of attaching the tapered catheter to the already implanted hepatic artery infusion pump and inserting catheter into the splenic artery.The physician did not insert a new pump and kept the existing pump implanted in the patient's body.Therefore, there was no malfunction towards the pump, and it's working as intended.The physician reported that everything went well.In addition, pseudoaneurysm is a known adverse event on the labeling of the codman 3000 pump.

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTED DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; suite 300a; newton MA 02459
• Manufacturer Contact: jesus matos ; 180 wells avenue; suite 300a; newton, MA 02459
• MDR Report Key: 21743152
• Report Number: 3015537318-2025-00021
• Device Sequence Number: 9001501
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: 15953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: AP-03000H
• Device Catalogue Number: AP03000H
• Device Lot Number: 10263182
• 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: 03/05/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2018
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 60 KG