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

Model Number	NEXHD1552801
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device 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
Tr (b)(4): the device was successfully placed on (b)(6) 2016.On (b)(6) 2017, the patient had his 150 day review and it was discovered that he had been administered antiobiotics in the previous month for an exit site infection.A moderate exit site infection occured on (b)(6) 2017 with a definite device relationship.There was a small amount of purulent discharge from the exit site and the patient stated that the site was slightly tender per rn note.An exit site culture on (b)(6) 2017 was positive for citrobacter freundii.No action was taken with the study device and the infection was treated with vancomycin and ceftazidime.The event resolved on (b)(6) 2017.
Event or Problem Description
New information: the study site reported that the patient experienced a moderate crbsi event on (b)(6) 2017.The patient presented to the clinic with drainage from the exit site but no other complaints.Culture of the wound showed citrobacter freundii, coagulase negative staphylococcus and corynebacterium.Two sets of central blood cultures showed coagulase negative staphylococcus.Several doses of iv vancomycin and ceftazadime were given over several days.On 7 feb 2017, the decision was made to exchange the tcc (tunnelled cuffed catheter).The nexsite catheter was removed and disposed of on (b)(6) 2017.The event resolved on the same date.
Event or Problem Description
Additional information received from electronic database provider indicated the event that occurred on (b)(6) 2017 was a potential crbsi/ exit site infection.
Event or Problem Description
(b)(4): additional information provided by monthly site monitoring visit indicated metabolic acidosis in the past medical history.

• 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: 6310146
• Report Number: 3008110587-2017-00001
• Device Sequence Number: 16152538
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)170201(10)43335
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/30/2017

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 Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 43335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 07/11/2017
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 02/27/2017; 06/13/2017; 07/26/2017
• 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: 44 YR
• Patient Weight: 126