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

Catalog Number	NEXHD1552801
Health Effect - Clinical Codes	Death (1802); Cancer (3262)
Date of Event	04/24/2015
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device remained 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 " caused by other." the complaint investigation indicates another device/drug/procedure/illness/co-morbidity caused the complaint event.Per the death certificate, the immediate cause of death was renal cancer metastatic.End stage renal disease is listed as an underlying cause of death.The relationship to the study device is indicated as unrelated.
Event or Problem Description
Study (b)(4): the study device was successfully placed in this (b)(6) male patient on (b)(6) 2015.The patient died on (b)(6) 2016.Per the death certificate the immediate cause of death was renal cancer metastatic.End stage renal disease was listed as an underlying cause of death.The death was unrelated to the study device.

• 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: 5681246
• Report Number: 3008110587-2016-00021
• Device Sequence Number: 307328
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)160101(10)39413
• 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
• Report Date (Section B): 05/03/2016

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: 01/01/2016
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 39413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2016
• Initial Report FDA Received Date: 05/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHFLO ACTIVASE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Weight: 54