MAUDE Adverse Event Report: CODMAN & SHURTLEFF CODMAN 3000; IMPLANTABLE DRUG DELIVERY PUMP

Model Number	CODMAN 3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of the investigation, the device history record was reviewed, and found no nonconformances for the production lot.The codman 3000 high flow model is indicated for hepatic artery infusion of the liver for treatment of metastatic cancer.Infection is a known complication as listed on the labeling for the codman 3000.Since the physician's office stated that in their opinion the relationship between the device and infection is mutual exclusive, that the infection occured 8 months after implant, and the device history record does not contain any nonconformances, it suggests that the infection was not related to a sterility issue with the device as manufactured.Intera oncology monitors adverse events and there is no increased trend of infection that indicates a potential sterility issue with existing devices as manfuactured.
Event or Problem Description
Device tracking card was received from patient.Written on the card was "note - pump caused infection." the device was explanted (b)(6) 2019.The date written on the card by the initial reporter was (b)(6) 2021, the card was received in the mail by intera oncology on 04/28/2021.The physician's office was contacted and more information was obtained regarding the adverse event.As provided by the physician's office, the patient developed a cellultis infection (b)(6) on the incision over the pump approximately 8 months after implant.The patient was placed on suppressive antibiotics with cephalosporin for 1 year prior to removal of hai pump because of continued infection (described as 'rare (b)(6)').Infection was resolved after the explant of the pump.The physician's office described the relationship between the pump and the infection as "mutual exclusive.".

• Brand Name: CODMAN 3000
• Common Device Name: IMPLANTABLE DRUG DELIVERY PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11882338
• Report Number: 3015537318-2021-00020
• Device Sequence Number: 1413578
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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 Expiration Date: 03/31/2018
• Device Model Number: CODMAN 3000
• Device Catalogue Number: AP0300H
• Device Lot Number: H35506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/26/2021
• 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: Required Intervention
• Patient Age: 48 YR