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

Model Number	NEXHD1553201
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; 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) 2016.The tip of the catheter was positioned in the svc.The procedure report from the catheter placement procedure states that the patient had a reclotted left upper arm avg.The physician advised no more declot attempts and he plans a new right arm av access asap.He has had multiple chest catheters previously.The patient received cathflo on (b)(6) 2016.On (b)(6) 2016, the patient presented with a dysfunctional left internal jugular vein tdc (tunnelled dialysis catheter).The current catheter tip is in the svc and we do not have a catheter the appropriate length to reach the right atrium.Clotted access was indicated.A rij catheter could not be placed due to ij stenosis.Decision is made with the patient to place a femoral catheter for hd access."there was nothing wrong with the device.The subject had ij stenosis and needed a longer catheter for placement." the nexsite hd catheter was removed and the event had resolved on (b)(6) 2016.
Event or Problem Description
Additional information provided by the site: the event was unrelated to the study device.The dysfunction was associated with the placement length.
Event or Problem Description
Additional information provided by the study site indicated that the event was definitely related to the study device.It is also noted that cathflo was started on (b)(6) 2016 to treat the clotted catheter.

• Brand Name: NEXSITE HD STEPPED TIP
• Common Device Name: HEMODLALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• MDR Report Key: 6131298
• Report Number: 3008110587-2016-00037
• Device Sequence Number: 10852075
• Product Code: MSD
• UDI-Device Identifier: 05391525640044
• UDI-Public: (01)05391525640044(17)161101(10)42551
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2016

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: 11/01/2016
• Device Model Number: NEXHD1553201
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 42551
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided; 10/04/2017
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 12/05/2016; 10/10/2017
• 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: 37 YR
• Patient Weight: 140