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

Catalog Number NEXHD1552801

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Cancer (3262)

Event Date 04/24/2015

Event Type  Death  

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 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
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre,; gmit, dublin road,; galway, ; EI
• Manufacturer Contact: fiona geraghty ; innovation in business centre; gmit, dublin road,; galway, ; EI ; 91759301
• MDR Report Key: 5681246
• MDR Text Key: 45956664
• Report Number: 3008110587-2016-00021
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)160101(10)39413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/01/2016
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 39413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• Date Device Manufactured: 01/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CATHFLO ACTIVASE
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 54