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

Model Number	NEXHD1552801
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device 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
(b)(6): the nexsite device was successfully placed in this (b)(6) female on (b)(6) 2016.On (b)(6) 2016, an moderate infection was reported.Central bloods tested positive for (b)(6).Vancomycin was given to treat the event.The event had resolved on (b)(6) 2016.The device was removed from the patient on (b)(6) 2016 as it was no longer required.
Event or Problem Description
Additional information provided during data reconciliation: on (b)(6) 2016, the patient also experienced mild high venous pressure.This was treated with cathflo and the event had resolved on the same date.

• 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: 5553829
• Report Number: 3008110587-2016-00012
• Device Sequence Number: 707924
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)160301(10)40161
• 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): 03/14/2016

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: 03/01/2016
• Device Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 40161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 04/07/2016
• Supplement Report FDA Received Date: 12/19/2017
• 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: 39 YR
• Patient Weight: 96