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

Model Number	NEXHD1552801
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Nausea (1970); Vomiting (2144)
Date of Event	05/11/2016
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.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, a moderate infection was reported.The patient complained of being sick and her abdominal pain while attending dialysis.She spat up saliva with brown streaks.Blood cultures were taken that day and the patient attended the emergency department where she was diagnosed with chronic abdominal pain with episodes of vomiting.The subject returned to dialysis on (b)(6) 2016 with a temperature of 99.2f.Catheter care was performed and there were no reported signs of infection.Blood was obtained that day for blood cultures as well due to the patient's continuous nausea and vomiting.These bloods showed coagulase (b)(6).The device was removed on (b)(6) 2016 and vancomycin was given.The event resolved on the same date.
Event or Problem Description
Conclusion of the cec (clinical events committee) following adjudication of the adverse event: likely blood culture contaminant.Bloodstream infection not indicated.

• 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: 5690606
• Report Number: 3008110587-2016-00023
• Device Sequence Number: 88148
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)161101(10)42550
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2016

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: 01/11/2016
• Device Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 42550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2016
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/01/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 92