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

Model Number	NEXHD1552801
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2016
Type of Reportable Event	Malfunction
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
(b)(4): the device was successfully placed in this (b)(6) female patient on (b)(6) 2015.Poor flow was reported on 04 apr 2016.No action was taken with the study device.Cathflo was given to treat the poor flow.The event resolved on the same date.
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
The patient had her device removed on (b)(6) 2016 due to flow issues.The original flow issues were thought to be resolved after a dose of cathflo but ended up continuing.The device was disposed of after removal.
Event or Problem Description
Additional information provided by electronic data provider indicated that the (second) low flow event started on (b)(6) 2016.The event resolved on (b)(6) 2016.

• 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: 5643108
• Report Number: 3008110587-2016-00018
• Device Sequence Number: 13506343
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/12/2015
• Device Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 40161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2016
• Supplement Date Received by Manufacturer: Not provided; 06/26/2017
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 05/13/2016; 07/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 128