MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported that a vital-port infusion port was implanted in the patient.A week later, it was discovered that the catheter had disconnected from the port.The patient was transferred to another hospital the next day and additional surgery was performed to remove the detached catheter.No additional consequences to the patient were reported.
Additional Manufacturer Narrative
Investigation summary: the complaint device was not returned, and therefore the quality engineering and engineering departments could not perform a physical examination.Catheter disconnect is a known failure mode of this device.It is being tracked and trended per the complaint handling processes.The instructions for use was reviewed and catheter disconnection, fracture and fragmentation are listed as potential adverse events.Also listed in the instructions for use is a warning stating "failure to adequately anchor the port to the fascia increases the risk of catheter fracture and/or disconnection which could result in catheter migration." the device history record was completed, including the manufacturing and quality control activities.All process steps were complete and signed off by trained personnel.There are no signs in the device history record to indicate that this device was shipped to the filed nonconforming.Since a physical investigation was not conducted on the device, a defect of the device or the manufacturing process is inconclusive.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT
• Common Device Name: LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7314662
• Report Number: 2522007-2018-00006
• Device Sequence Number: 13926524
• Product Code: LJT
• UDI-Device Identifier: 00827002264410
• UDI-Public: (01)00827002264410(17)171130(10)N125206
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K912423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S9112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 06/14/2018
• 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