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

Model Number AP03000H

Device Problem Component Missing (2306)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

As reported by intera clinical specialist, a surgeon implanted an intera 3000 hepatic artery infusion pump, serial number: (b)(4), with arterial flow rate 1.2 ml/day into a patient on (b)(6) 2022.It was reported that the catheter only had two beads on the catheter.When the scrub tech cut the knot off the end of the catheter, the clinical specialist did not see a bead near the catheter knot.The patient's gastroduodenal artery (gda) was very long and the surgeon was able to implant the catheter into the artery without issue.No patient injury reported.The defect was discovered as the surgeon was implanting the catheter, and the clinical rep did not notice this when they were prepping the pump.It is undetermined if the missing bead had been inadvertently cut off when the scrub tech cut off the knot or if the missing bead was actually missing (e.G.Had fallen off) with the pump as delivered to the operating room.

Manufacturer Narrative

The manufacturing records were reviewed and no nonconformities or deviations were noted for this serial number.As stated in the event description, it is undetermined if the bead was missing as delivered or if the bead was inadvertently cut off during pump prep.Missing information in the mdr form represents unknown information.If further information is received, a supplemental report will be filed.

• 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: 15764468
• MDR Text Key: 307736435
• Report Number: 3015537318-2022-00024
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 28816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 82 KG