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	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/18/2016
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
International customer reported that a patient had a vital-port vascular access system implanted for an unspecified indication.The specific site and route of implantation was not provided.The device allegedly broke at an unspecified time following implantation.The signs, symptoms, circumstances and conditions that prompted a return of the patient and indicated a break of the device were not provided.X-rays were taken and confirmed that device broke / separated.The patient returned to the hospital for explant of the port and removal of the catheter from the right atrium.One of the pediatric physicians with knowledge of the event provided additional details stating that the patient was admitted to the hospital under the pediatric cardiology and adult interventional radiology services."the tubing and the device itself were completely separated and the tubing had migrated into the patient so that the tip lay in the right ventricle.This posed a risk for cardiac arrhythmia as well as pulmonary embolus." "the patient was not symptomatic but was at risk of a life threatening complication should an arrhythmia or embolus occur." the patient underwent a procedure to remove the catheter by way of interventional radiology and a separate procedure under general anesthesia to remove the vital-port.No further event or patient status details were provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter had fractured.The broken portion had a rough appearance, with jagged surfaces on the edges.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6332169
• Report Number: 2522007-2017-00004
• Device Sequence Number: 1106123
• Product Code: LJT
• UDI-Device Identifier: 00827002264496
• UDI-Public: (01)00827002264496(17)160531(10)N113689
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S6112
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: 06/02/2017
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 08/09/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention