MAUDE Adverse Event Report: INTERA ONCOLOGY INTERA 3000; HEPATIC ARTERY INFUSION PUMP

Model Number AP03000H

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

Further follow up with the customer is ongoing to obtain further clarity on the nature of the complaint; at the time of this report, it is determined based on information available the adverse event is related to surgical technique and surgeon preference for positioning of the device.Patient information has been requested but not yet received at the time of this report.If further information is received, a supplemental report will be filed.

Event Description

A device tracking card for a patient, serial number (b)(4) and implant date of (b)(6) 2023, was received on 06 february 2023.Patient's name was in the intera device tracking system had been previously implanted with sn (b)(4) on (b)(6) 2022.Therefore, it is determined that a revision surgery was performed.No additional information was supplied by the hospital in advance or at the time of the revision.Further out reach to the hospital after receipt of the card was conducted, and it was stated by the hospital that "[the surgeon] couldn't get the original device adjusted the way he wanted so he replaced it with a new one.Nothing was wrong with the original device." further details were not provided.

• Brand Name: INTERA 3000
• Type of Device: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• Manufacturer (Section G): INTERA ONCOLOGY; 65 william street; suite 200; wellesley MA 02481
• Manufacturer Contact: sarah lapp ; 65 william street; suite 200; wellesley, MA 02481 ; 7814895724
• MDR Report Key: 16452384
• MDR Text Key: 310338421
• Report Number: 3015537318-2023-00007
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00850014110147
• UDI-Public: 00850014110147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 28432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention