MAUDE Adverse Event Report: MARVAO MEDICAL NEXSITE HD STEPPED; HEMODIALYSIS CATHETER

Catalog Number	NEXHD1552801
Health Effect - Clinical Codes	Chest Pain (1776); Purulent Discharge (1812); Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Swelling (2091); Vomiting (2144); Chills (2191)
Date of Event	09/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device remains implanted; therefore an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirmed that the lot met the specification requirements.The review found no deviations or non-conformances that would have contributed to the reported complaint.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of an anticipated procedural complication.A complaint with a most probable root cause classification of an anticipated procedural complication indicates that a device related root cause does not apply and the complaint is due to a known effect of the procedure.
Event or Problem Description
(b)(6): the nexsite device was placed successfully on (b)(6) 2016.At her 90 day review on (b)(6) 2016, there was no report of any adverse event.On (b)(6) 2016, the patient presented to the emergency department complaining of chest pain to touch and drainage from her dialysis port on the right side of her chest.Patient describes her port to be "oozing and painful" and also complains of chills and vomiting green fluids.She admits to missing her most recent dialysis appointments due to a fever following a flu shot 4-5 days ago.On examination of the skin, serous fluid with bloody tinge, slightly purulent drainage with moderate swelling and mild erythema to right chest dialysis port was reported.Pus was expressed from around the port and swabbed and sent for culture.(b)(6) was reported in the wound culture.This patient had a history of skin (b)(6).Blood cultures were also obtained but these results are not available.No action was taken with the study device.Given the lack of fever, the patient being relatively well-appearing and the white count being only 13.1, empiric treatment with invanz was recommended.Doxcycline was started on (b)(6) 2016.Lasix was also given to decrease her potassium.At the patient's day 120 review on (b)(6) 2016, an exit site infection was confirmed as occuring on (b)(6) 2016.A crbsi event was not confirmed.The patient is currently in the hospital with an infection, but no records have not been sent yet.
Event or Problem Description
Follow-up information: the patient had the catheter removed sometime in the beginning of (b)(6) and the catheter was determined to be the cause of the infection which has now developed into sepsis.The patient is still hospitalised at a large university hospital in icu.Due to the patient's status, we are unable to obtain a signature for an authorization to release records from this facility.The patient outcome is unknown/lost to follow-up.

• Brand Name: NEXSITE HD STEPPED
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• MDR Report Key: 6056528
• Report Number: 3008110587-2016-00033
• Device Sequence Number: 1665847
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)161101(10)42550
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2016

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: Physician
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 42550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 12/15/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 88