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

Model Number	NEXHD1552801
Health Effect - Clinical Codes	Pain (1994); Fluid Discharge (2686)
Date of Event	08/25/2015
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)(6): the nexsite device was successfully placed on (b)(6) 2015.It was reported that the subject came to vascular access unit on (b)(6) 2015 for a catheter removal due to access no longer needed/viable fistula in place.Upon being queried about antibiotics by monitor on (b)(6) 2016, study coordinator noted that antibiotics vancomycin and cefepime were administered due to moderate drainage prior to device removal on (b)(6) 2015.The site monitoring visit in (b)(6) 2017 referenced drainage around the disc had resulted in device removal.Patient records indicated that the patient presented with complaints of severe pain to the right side of his neck near cath.Cath disk has small opening at the top, and has tan discharge.No evidence of purulent discharge.The event had resolved on the same date ((b)(6) 2015).Dressings were applied to the cannulation sites which were dry and intact at time of discharge.
Event or Problem Description
Conclusion of the cec (clinical events committee) following adjudication of the adverse event: exit site infection/complications.

• Brand Name: NEXSITE HD STEP 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: 6536329
• Report Number: 3008110587-2017-00006
• Device Sequence Number: 13606915
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)160101(10)39413
• Combination Product (Y/N): N
• PMA/510(K) Number: K121933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2017

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: 01/01/2016
• Device Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 39413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/02/2017
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 104