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

Catalog Number	NEXHD1553201
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Staphylococcus Aureus (2058)
Date of Event	04/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device 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.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 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
(b)(4): the nexsite device was successfully placed in this patient on (b)(6) 2016.On (b)(6) 2016, mild malposition of her catheter with inability to run her dialysis treatment was reported.The same catheter remained, the catheter was just untwisted and repositioned.The event resolved on the same date.On (b)(6) 2016, the patient experienced mild bacteremia with (b)(6) of unknown primary.The patient had a fever and wbcs of 21.4.Peripheral bloods showed (b)(6) while central bloods were not taken.While the source of the bacteremia was unknown, a uti or pneumonia was suspected.The exit site was clean, the tunnel tract was clean and when the antibiotics were discontinued, the catheter was still being used without problems.Vancomycin as given to treat the event and the event resolved on (b)(6) 2016.
Event or Problem Description
Additional information: it was confirmed that no urine analysis or culture was done on the patient.Chest x-ray demonstrated infiltrates felt to be consistent with pneumonia.

• Brand Name: NEXSITE HD 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: 5771530
• Report Number: 3008110587-2016-00026
• Device Sequence Number: 315229
• Product Code: MSD
• UDI-Device Identifier: 05391525640068
• UDI-Public: (01)05391525640068(17)161101(10)42551
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133796
• 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): 06/13/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 42551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 07/28/2016
• 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: ESCITALOPRAM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 138