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

Model Number	NEXHD1553201
Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	01/03/2016
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 could affect product quality.The manufacturer has requested additional information regarding the incident.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 successfully placed on (b)(6) 2015.On (b)(6) 2016, there was pain and erythema at catheter exit site.Vancomycin was given to treat the event.Central bloods were taken on (b)(6) 2016 and were found to be negative.No action was taken with the study device.
Event or Problem Description
Additional information received from electronic database provider indicates that the erythema event had resolved on (b)(6) 2016 and the pain at the catheter site resolved on (b)(6) 2016.
Event or Problem Description
Conclusion of the cec (clinical events committee) following adjudication of the adverse event: event categorised as an exit site infection/exit site complication.A comprehensive record review was completed at the site.According to the record review, no abx were administered on (b)(6) (the date of the blood draw).

• Brand Name: NEXSITE STEPPED TIP
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre,; gmit, dublin road,; galway, ; EI
• MDR Report Key: 5436196
• Report Number: 3008110587-2016-00005
• Device Sequence Number: 997165
• Product Code: MSD
• UDI-Device Identifier: 05391525640044
• UDI-Public: (01)05391525640044(17)160101(10)39352
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/01/2016
• Device Model Number: NEXHD1553201
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 39352
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2016
• Supplement Date Received by Manufacturer: Not provided; 06/25/2018
• Initial Report FDA Received Date: 02/15/2016
• Supplement Report FDA Received Date: 04/26/2017; 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75