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

Model Number	NEXHD1553201
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Herpes (1898); Unspecified Infection (1930); Staphylococcus Aureus (2058); Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Date of Event	07/07/2016
Type of Reportable Event	Serious Injury
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.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 discharge note, it is thought that the source of the infection was most likely due to the severe case of herpes zoster the subject suffered in that area.
Event or Problem Description
(b)(6): the device was successfully placed on (b)(6) 2016.On (b)(6) 2016, this patient presented with shingles (severe) which was considered unrelated to the device and was treated with sulfate cream - gentamycin and valtrex and the event resolved on (b)(6) 2016.On (b)(6) 2016, the patient was documented to have an altered mental state of moderate severity which was not considered related to the study device and resolved on the same day without treatment.The staff at the clinic noted on (b)(6) 2016 that the patient had a fever of 40+ degrees celsius with shaking rigors.Blood cultures were drawn.On (b)(6) 2016, the patient had the device removed due to bacteremia of moderate severity which is considered unlikely related to the study device.It was thought that the source of the infection was most likely from skin contaminate of herpes zoster the subject suffered from in that area.Treatment for the bacteremia included levaquin, zosyn and vancomycin.The bacteremia had resolved on (b)(6) 2016.The hospital discharge note from (b)(6) 2016 noted that the tunnel catheter was clean and did not appear infected.The final results for whole blood cultures were positive for staphylococcus aureus.The hospital does not clarify whether they were central or peripheral bloods.
Event or Problem Description
Conclusion of the cec (clinical events committee) following adjudication of the adverse event: infection - possible crbsi.The physical exam on the discharge summary states skin has "no rashes, or lesions".

• Brand Name: NEXSITE HD STEPPED TIP DEVICE
• 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: 5867926
• Report Number: 3008110587-2016-00028
• Device Sequence Number: 10879279
• Product Code: MSD
• UDI-Device Identifier: 05391525640044
• UDI-Public: (01)05391525640044(17)161101(10)42551
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2016

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: 11/01/2016
• Device Model Number: NEXHD1553201
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 42551
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 07/10/2018
• 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: METOPROLOL
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 47 YR
• Patient Weight: 106