MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN; TAPERED CATHETER

Model Number	IP37957
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the codman tapered catheter was not available from patient records.Intera reviewed the lot history records from tapered catheters produced in 2019 and found there were no nonconformances, all parts and components were accounted for.If further information is received at a later time, a supplemental report will be filed.
Event or Problem Description
Combined primary resection with hepatic artery infusion pump implantation is safe for unresectable colorectal liver metastases was published in the journal of gastrointestinal surgery and published online 24 november 2021.This publication is a retrospective study of 32 patients who underwent hepatic artery infusion (hai) pump placement for treatment colorectal cancer metastatic to the liver.The hai pump was described as medtronic synchromed ii programmable pump spliced to the codman tapered catheter.Hai-related complications that were published were: pump pocket seroma (11%), gastroduodenal artery pseudoaneurysm (5%), biliary sclerosis (5%), pump pocket hematoma (8%), hepatic arterial dissection (8%), extrahepatic perfusion (8%), and pump pocket infection (8%).The adverse event related to the use of the tapered catheter that was reported was gastroduodenal artery pseudoaneurysm.The article reports that "one patient in the combined group accounted for both an early pump pocket seroma and a delayed arterial pseudoaneurysm.The pseudoaneurysm occurred during an episode of pancreatitis approximately 8 months after hai pump placement and following definitive hepatic resection." follow up with the studies authors was conducted to obtain further information regarding the use of the tapered catheter.The surgeon described approximately 9-10 months after pump was implanted, the patient had a 2nd stage liver operation to resect remaining liver metastases after the course of hepatic artery infusion treatment.Patient had finished the course of hepatic artery infusion treatment and thus was not on any pump-infusion medications at the time.Patient was also covid-19 around the same time of surgery which, in the surgeon's opinion, caused pancreatitis which likely caused hemorrhage which caused the pseudoaneurysm.Exact date of covid-19 diagnosis was not provided.Surgical intervention was taken to stop gi bleeding.Codman tapered catheter lot number was not provided.

• Brand Name: CODMAN
• Common Device Name: TAPERED CATHETER
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• 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: 13087688
• Report Number: 3015537318-2021-00030
• Device Sequence Number: 20261453
• Product Code: LKK
• UDI-Device Identifier: 10886704044086
• UDI-Public: 10886704044086
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2021

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: 11/29/2021
• Initial Report FDA Received Date: 12/27/2021
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White