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

Model Number CODMAN 3000

Device Problems Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 12/20/2005

Event Type  Injury  

Manufacturer Narrative

Exact explant date is not known and is estimated.Sufficient information to make a determination of the adverse event is not available at this time.Intera has contacted the physician's institution in order to obtain more information about the nature of the product problem, but has not received additional information at the time of this report.If additional information is received, a supplemental report will be filed.

Event Description

Patient called clinical call line in response to device tracking mailing stating that the "pump was blocked and bothering her." patient states pump was removed 4 years ago.

Event Description

Additional information was provided from patient's health care provider.The health care provider stated that the patient had a codman 3000 drug delivery pump implanted for hepatic arterial infusion.They stated that five days after implantation, patient had post-surgery abnormal hepatic flow.A diagnostic arteriogram found that the common hepatic artery was dissected and occluded.Vascular dissection and subsequent occlusion/thrombosis may occur due to malposition of the catheter in artery during implant.Vessel thrombosis is a known procedural complication as listed on the labeling of the codman 3000.Heparinized saline was being administered in the pump at the time of the adverse event.Explant date was not provided.

Manufacturer Narrative

Updated information based on feedback from the patient's healthcare provider.Blank fields in the mdr form represents unknown information.

• Brand Name: CODMAN 3000
• Type of Device: IMPLANTABLE DRUG INFUSION PUMP
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 11838720
• MDR Text Key: 251119244
• Report Number: 3015537318-2021-00011
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 10886704043591
• UDI-Public: 10886704043591
• Combination Product (y/n): Y
• PMA/PMN Number: P890055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CODMAN 3000
• Device Catalogue Number: AP03000H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 59