MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000; HEPARTIC ARTERY INFUSION PUMP

Model Number	AP03000H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pseudoaneurysm (2605); Gastrointestinal Hemorrhage (4476)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event occured in 2018, and the device was explanted in 2019 after course of treatment was completed.Intera did not acquire the product line and reporting responsibilities until 2020, but is making this report based on what was found in the literature.Intera oncology reached out to one of the abstract authors to obtain more information to file this report.The physician stated the device did not appear damaged.Intera was able to determine the serial number based off of the device tracking information and reviewed the device history record (dhr).The dhr for this serial number was reviewed and no nonconformities were noted in the manufacture.Known adverse events listed in the codman ifu include: catheter thrombosis, bolus path occlusion, vessel thrombosis, pump dislodgement, seroma or recurrent hematoma, infection, extravasation, catheter shear, dislodgement or leakage, and migration.There is no currently indication of an increased trend of this adverse event.
Event or Problem Description
This report is being made upon identifying an abstract in the 2020 acg annual meeting abstracts, october 2020 volume 115, published online 02 november 2020.Abstract titled: hemobilia due to arteriobiliary fistula from a hepatic artery infusion pump pseudoaneurysm.The abstract included details of a possible adverse event involving hepatic artery infusion therapy that may be device-related.Specifically according to the abstract: ct demonstrated a 36 mm hypoattenuating collection at the tip of the hepatic artery pump causing biliary duct compression and upstream dilation.Ercp (endoscopic retrograde cholangiopancreatography) was performed which demonstrated a moderate biliary stricture at the level of the haip tip and a plastic biliary stent was placed.Patient re-presented 3 weeks later with increased abdominal pain, melena, and jaundice.Ct angiogram (cta) demonstrated a 26 mm thrombosed pseudoaneurysm in the gda at the tip of the haip without active bleeding.Repeat ercp showed hemobilia and clots with a 20 mm cavity seen in the middle third of the bile duct.A covered metal stent was placed across this area.Patient presented 10 days later with recurrent symptoms and underwent cta that showed hyperattenuating material in the common bile duct with biliary dilation.Arteriogram was negative for active extravasation or pseudoaneurysm, with the gda not opacified.Ercp was repeated which revealed an occluded biliary stent with blood products.Balloon sweeps were performed which lead to migration of the proximal end of the stent to the level of the known pseudoaneurysm and active bleeding was noted.A new covered metal stent was placed and bleeding subsided.Repeat arteriogram showed active bleeding from the gastroduodenal artery stump into a 20 mm collection between the biliary stent and the haip tip, which was treated with hepatic artery stent grafting.Patient later had device explanted as course of treatment was completed.

• Brand Name: CODMAN 3000
• Common Device Name: HEPARTIC ARTERY INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 10929604
• Report Number: 3015537318-2020-00014
• Device Sequence Number: 2631633
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: AP03000H
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 87