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

Catalog Number	NEXHD 1552401
Health Effect - Clinical Code	Death (1802)
Date of Event	09/22/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device is not available for return; 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.Taking into consideration the evaluation conducted and the details of the complaint, this investigation is assigned the most probable root cause of unknown.A complaint with a most probable root cause classification of unknown indicates that a device-related root cause does not apply.Despite numerous attempts to get more information on the cause of death, no new information has been received.Should additional information be obtained, the root cause of the complaint will be reviewed.
Event or Problem Description
Study (b)(4): the nexsite device was successfully placed on (b)(6) 2016.On (b)(6) 2016, the patient died at home.The cause of death is unknown at this time.
Additional Manufacturer Narrative
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 other co-morbidities caused the complaint event.Per the death certificate, significant conditions that contributed to the death include crf, htn, copd and anemia.While a possible device relationship was indicated, the most probable root cause of the death is the underlying co-morbidities.
Event or Problem Description
Additional information provided by the site: the death certificate indicated that the sudden cause of this natural death was a myocardial infarction.Other significant conditions contributing to the death include crf (chronic renal failure), htn (hypertension), copd (chronic obstructive pulmonary disease) and anemia.

• Brand Name: NEXSITE STEPPED TIP
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• MDR Report Key: 6128405
• Report Number: 3008110587-2016-00038
• Device Sequence Number: 10818825
• Product Code: MSD
• UDI-Device Identifier: 05391525640006
• UDI-Public: (01)05391525640006(17)161001(10)42458
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,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
• Operator of Device: Physician
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: NEXHD 1552401
• Device Lot Number: 42458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 12/02/2016
• 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: Death
• Patient Age: 68 YR
• Patient Weight: 58