MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000; HEPATIC ARTERY INFUSION PUMP

Model Number	AP03000H
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Thrombosis (2100); Stomach Ulceration (4488)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intera oncology purchased the rights to the codman hepatic artery infusion pump january 2020.The adverse events reported in this article occured from 2003-2017.Intera reviewed the past complaint data and was unable to determine if any of the complaints were previously reported to the fda.Intera contacted the corresponding author for the report for aggregate information for reporting.The corresponding author declined to provide further information.This report is being made in accordance with mdr guidance section 4.16.2.Event codes are attached to this submission.If intera obtains more information about these events from either the corresponding author or other authors, a supplemental report will be filed.The complications reported in the article are known complications of the device or of fudr treatment.Known adverse events of hepatic artery infusion reported in the ifu include: catheter thrombosis, bolus path occlusion, vessel thrombosis, pump dislodgement, seroma, or recurrent hematoma, infection, extravasation, catheter shear, dislodgement or leakage, and migration.
Event or Problem Description
An article published in the journal of surgical oncology, 23 october 2020: "safety and feasibility of initiating a hepatic artery infusion pump chemotherapy program for unresectable colorectal liver metastases: a multicenter, retrospective cohort study." the study included patients from 2003-2017 and included pump-related adverse events.These events may or may not have been reported to the fda in previous mdr reports.Pump-related adverse events that were reported include: pump pocket (n=14), infection (n=7), hematoma (n=2), migration (n=2), unspecified (n=2), hepatic arterial system (n=10), thrombosis (n=2), incomplete perfusion (n=4), bleeding (n=4), catheter (n=3).Long term complications reported include: biliary sclerosis (n=13), other (n=4), duodenal ulcer (n=1), delayed pump infection (n=2), pump flipped requiring reoperation (n=1).
Additional Manufacturer Narrative
Corresponding author declined request to provide additional detail information regarding the adverse events reported.
Event or Problem Description
An article published in the journal of surgical oncology, 23 october 2020: "safety and feasibility of initiating a hepatic artery infusion pump chemotherapy program for unresectable colorectal liver metastases: a multicenter, retrospective cohort study." the study included patients from 2003-2017 and included pump-related adverse events.These events may or may not have been reported to the fda in previous mdr reports.Pump-related adverse events that were reported include: pump pocket (n=14), infection (n=7), hematoma (n=2), migration (n=2), unspecified (n=2), hepatic arterial system (n=10), thrombosis (n=2), incomplete perfusion (n=4), bleeding (n=4), catheter (n=3).Long term complications reported include: biliary sclerosis (n=13), other (n=4), duodenal ulcer (n=1), delayed pump infection (n=2), pump flipped requiring reoperation (n=1).

• Brand Name: CODMAN 3000
• Common Device Name: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 10892059
• Report Number: 3015537318-2020-00013
• Device Sequence Number: 2799144
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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 Model Number: AP03000H
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR