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

Catalog Number	NEXHD1552401
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2016
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 and the review found no deviations or non-conformances that could affect product quality.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): this (b)(6) old patient had a nexsite device placed successfully on (b)(6) 2015.On (b)(6) 2016, the device had moderate poor flow.No action was taken with the study device.Activase was given to treat the event.The event resolved on the same day.There was a second occurrence of moderate low flow on (b)(6) 2016.Activase was given again and the event had resolved by (b)(6) 2016.No action was taken with the study device.

• Brand Name: NEXSITE STEPPED
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre,; gmit, dublin road,; galway, ; EI
• MDR Report Key: 5403565
• Report Number: 3008110587-2016-00002
• Device Sequence Number: 508989
• Product Code: MSD
• UDI-Device Identifier: 05391525640006
• UDI-Public: (01)05391525640006(17)160201(10)39789
• 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
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Report Date (Section B): 01/11/2016

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: 02/01/2016
• Device Catalogue Number: NEXHD1552401
• Device Lot Number: 39789
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 78