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

Model Number AP03000H

Device Problem Use of Device Problem (1670)

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

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed and there were no nonconformances or deviations pertaining to this serial number.The device met all functional and performance specifications prior to release from manufacturing.The device remains implanted in the patient at the time of this report.Based on the discussion with the circulating nurse after surgery in which it was stated that the incorrect needle may have been used, and the fact that it was stated that methylene blue was returned into the syringe after injection, it is surmised that the surgeon may have utilized the refill needle to attempt a bolus injection instead of the special bolus needle.Both the refill needle and special bolus needles are labeled for their use on the labeling and in the instructions for use.If additional information is received at a later date, a supplemental report will be filed.

Event Description

Intera clinical was providing remote case coverage for the implantation of an intera 3000 hepatic artery infusion pump, serial number (b)(6).The following was reported: the circulating nurse called during the case to make sure the pump was prepped correctly as they did not see a bead after the pump [during prep] was cooled down.She said they did not see a bead come out the end of the catheter after flushing with the special bolus needle (sbn).They were instructed to use a second sbn and try again and they were able to successfully flush the catheter and bolus pathway.They reheated the pump and flushed the catheter with the low dose heparin using the special bolus needle (sbn).After the pump was reheated to 120f and the catheter flushed, they did see a bead.The pump was then cooled down to 95f and they saw the pump beading constantly after this time.They were verbally walked through the pump prep procedure as they had questions about when the pump could be completely submerged after emptying and filling the pump.They were instructed they could submerge the pump with pre-warmed fluid after it is emptied, filled and the catheter was flushed.Then instructed to cool down to 95 degrees f, dab off any drops that may have formed and wait 10 minutes to see another bead.Then the pump may be implanted.They called back when the physician was ready to test the catheter flow during the case (after implantation into the gastroduodenal artery (gda)) and they stated they were having trouble flushing the catheter.They also stated that the methylene blue that injected came back in the syringe.He took the catheter back out of the gda to see if they saw flow through the catheter.Intera clinical instructed them to make sure they were using the correct sbn to flush the methylene blue through the catheter to the gda.They reported that they were able to flush eventually with the sbn and saw flow into the liver with some extrahepatic flow.After this, there were some other [unreported] complications with the surgery but these reportedly did not involve the pump.The pump was implanted.Afterwards, the circulating nurse spoke with intera clinical and suggested that the surgeon may have been given the incorrect needle (a refill needle instead of a special bolus needle) to flush the catheter, which may have contributed to the difficulty in bolusing the catheter.

• 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
• MDR Report Key: 17855979
• MDR Text Key: 324742953
• Report Number: 3015537318-2023-00039
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP03000H
• Device Catalogue Number: AP-03000H
• Device Lot Number: 27663661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White