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

Model Number	NEXHD1553201
Health Effect - Clinical Codes	Fever (1858); Staphylococcus Aureus (2058); Alteration In Body Temperature (2682); Test Result (2695)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device has been disposed; 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
Study (b)(4): the nexsite device was successfully placed on (b)(6) 2017.On (b)(6) 2017, the patient presented with fever and chills and a wbc serum count of 28,000.Microbiological analysis was completed on a swab taken from the catheter exit site and on a peripheral blood sample.Both samples tested positive for staphylococcus aureus.No central bloods were taken.Vancomycin was given; however it was decided to remove the catheter on (b)(6) 2017 and the event resolved on the same date.The doctor indicated that there was no other apparent source of infection, but did wonder did the issue arise due to the patient having a non tunneled catheter.Prior to placement, the patient was dialysing with a non-tunneled hemodialysis catheter.The non tunneled catheter was not removed as a result of any complication and the patient had no symptoms of infection on the day on enrollment.
Event or Problem Description
Conclusions of the cec (clinical events committee) following adjudication of the adverse event: crbsi with exit site infection.

• Brand Name: NEXSITE HD STEPPED TIP
• 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: 6383304
• Report Number: 3008110587-2017-00003
• Device Sequence Number: 18963090
• Product Code: MSD
• UDI-Device Identifier: 05391525640044
• UDI-Public: (01)05391525640044(17)010417(10)43968
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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: 04/01/2017
• Device Model Number: NEXHD1553201
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 43968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 07/10/2018
• 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: Hospitalization
• Patient Age: 33 YR
• Patient Weight: 73