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

Model Number	AP03000H
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reporter provided some information regarding event as the treating physician; however, she was not the primary oncologist or surgeon for this patient and as such was unable to provide all of the requested information regarding current drug regimen and suspected cause of event at the time of this report.The lot history for this serial number (work order 10263305) was reviewed and no nonconformities pertaining to this serial number were noted on the device history record.Catheter dislodgement is a known complication to hepatic artery infusion therapy and is published in the codman ifu.Catheter dislodgement may occur due to the initial surgical technique of placing the catheter, but migration may occur slowly over time.The investigation will remain open to obtain more information from the primary oncologist as to specific cause of the adverse event; if further information is received from the primary oncologist, it will be filed in a supplemental report.
Event or Problem Description
Patient admitted (b)(6) 2020 with a codman pump place 2 years ago at another institution.Reporter does not suspect pump has malfunctioned as the patient had it refilled 2 weeks age and was actively receiving chemotherapy.Reporter suspects that the catheter tip became dislodged from the lumen of the artery.They requested a special bolus needle so they may investigate further.Reporter institution performed a pump study/angiogram to confirm that the pump catheter tip was partially out of the lumen on the gastroduodenal artery (gda).When the pump was accessed and contrast was injected into the catheter, contrast filled the hepatic arteries but also extravasated outside of the vessel lumen.A stent graft was placed across the gastroduodenal artery stump in order to exclude the hepatic artery infusion catheter, and prevent any further bleeding from the partially malposition catheter tip.At the time of this investigation and report, patient was reported as stable.

• Brand Name: CODMAN 3000
• Common Device Name: HEPATIC ARTERY INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11039479
• Report Number: 3015537318-2020-00015
• Device Sequence Number: 1047386
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2020
• 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: 12/04/2020
• Initial Report FDA Received Date: 12/18/2020
• 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: 63 YR
• Patient Weight: 33