MAUDE Adverse Event Report: INTERA ONCOLOGY INTERA; TAPERED CATHETER

Model Number	IP37957
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the tapered catheter is unknown.The operation of the non-intera pump is unknown.The intera tapered catheter was previously used for compassionate use or with ide to perform hepatic artery infusion with non-intera pumps.Blank information in the mdr form represents unknown information.If additional information is received, a supplemental report will be filed.
Event or Problem Description
It was reported that a patient with a intera tapered catheter spliced to a non-intera infusion pump was occluded.The patient was to undergo revision surgery to replace the non-intera pump with an intera pump.It was determined by the surgeon that the catheter closest to the gda (gastroduodenal artery) was occluded.The occlusion may or may not have been related to the operation of the non-intera pump.The planned revision with the intera pump was aborted.

• Brand Name: INTERA
• Common Device Name: TAPERED CATHETER
• 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: 17515927
• Report Number: 3015537318-2023-00033
• Device Sequence Number: 5607896
• Product Code: LKK
• UDI-Device Identifier: 00850014110093
• UDI-Public: 00850014110093
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2023

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
• Operator of Device: Health Professional
• Device Model Number: IP37957
• 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: 07/13/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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