MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932)
Date of Event	04/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: vital-port attached silicone catheter with int titanium power injectable port.Common device name: lit catheter, angioplasty, peripheral, transluminal.(b)(4).510(k) #: k150733.Investigation / evaluation.No images nor device were returned; however, during the course of investigation, a review of the complaint history, device history record and documentation was conducted.A review of manufacturing records and all process parameters were found to be within specifications, no deviations were filed for the sterilization run, no anomalies were found in temperature, concentration, and no damage was observed on product returned from sterilization.There are no signs of a sterility failure.As no product was returned and based on the limited information provided, we are unable to determine with certainty the root cause of this complaint.Per the quality engineering risk assessment (qera) no further action is required.The appropriate personnel have been notified and we will continue to monitor this device.
Event or Problem Description
Information was provided that the vital-port was inserted on (b)(6) 2016 and removed on the (b)(6) 2016 from the (b)(6) female patient with pre-existing condition of cancer, due to what appeared to be signs of infection or a reaction.The physician stated that the patient was not immunosuppressed nor had allergies.However, the patient had redness at the port pocket, the tunneled tract and also at the insertion site.The wound port pocket site also displayed signs of weeping; therefore, the patient could not receive her chemo treatment.The port was removed and sent to the facility's pathology department.For culture.No unexpected part of the device remained inside the patient; however, the patient will require an additional procedure due to this occurrence; patient was given cephazolon antibiotics and port is being removed with the next 24 hours.The initial reporter did not specify any adverse effects to the patient as a result of this event, however the description of event states: patient had redness at and above the port pocket and was warm to touch but not below, there was also redness at the insertion site.

• Brand Name: VITAL-PORT
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5676835
• Report Number: 1820334-2016-00331
• Device Sequence Number: 337254
• Product Code: LJT
• UDI-Device Identifier: 00827002264342
• UDI-Public: (01)00827002264342(17)190131(10)N134914
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2016

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 Model Number: N/A
• Device Catalogue Number: IP-S7010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 05/24/2016
• 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: 78 YR