MAUDE Adverse Event Report: INTERA ONCOLOGY, INC INTERA TAPERED CATHETER

Model Number	IP-37957
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The specific device in the report was not identified and it is assumed it may include an intera oncology device, likely a tapered catheter.Follow up attempts to obtain more information with the corresponding author went without a response.Hematoma is a known adverse event that is published and listed in the intera 3000 hepatic artery infusion pump information for use.If additional information is received, a supplemental report will be filed.Blank fields in the mdr form represent unknown information at the time of this report.
Event or Problem Description
Literature citation: dutta, a.K., shankar, v., santos, e.G.Et al.Percutaneous transhepatic arterial access for coil embolization of hepatic artery infusion pump-associated bleeding.Cvir endovasc 8, 5 (2025).Https://doi.Org/10.1186/s42155-024-00515-w.Case presentation a patient presented with an enlarging hematoma due to bleeding at the gastroduodenal artery haip (hepatic artery infusion pump) catheter insertion site.Emergent angiography revealed concomitant common hepatic artery occlusion and retrograde perfusion of the gda via tortuous, diminutive hepatic collaterals which precluded standard antegrade approach.Collateral infow from the dorsal pancreatic artery was utilized to opacify the right hepatic artery.The segment 5 hepatic artery was percutaneously accessed under fluoroscopic guidance, and microcoils were deployed both proximal and distal to origin of the gastroduodenal artery.The patient remained stable throughout the postoperative period and was discharged after an otherwise uneventful admission.Follow-up computed tomography demonstrated resolution of the hematoma and no bleeding or biliary complication from transhepatic access.

• Brand Name: INTERA TAPERED CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): INTERA ONCOLOGY, INC; 180 wells avenue; ste 300a; newton MA 02459
• Manufacturer (Section G): INTERA ONCOLOGY, INC; 180 wells avenue; ste 300a; newton MA 02459
• Manufacturer Contact: sarah lapp ; 180 wells avenue; ste 300a; newton, MA 02459 ; 7814895724
• MDR Report Key: 21316042
• Report Number: 3015537318-2025-00007
• Device Sequence Number: 12874759
• Product Code: LKK
• UDI-Device Identifier: 00850014110093
• UDI-Public: 00850014110093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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 Model Number: IP-37957
• Device Catalogue Number: IP37957
• 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: 01/11/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown