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

Model Number	NEXHD1552401
Health Effect - Clinical Codes	Fatigue (1849); Fever (1858); Pain (1994); Vomiting (2144); Discomfort (2330)
Date of Event	09/29/2016
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
Tr 0147 was successfully placed on (b)(6) 2016.On 29 sep 2016, a potential crbsi (catheter-related blood stream infection) was reported."at the beginning of treatment, pt tired and back hurt, pt.Attempted to rest but uncomfortable, midway thru treatment she began vomiting thick mucus.Goal decreased and treatment shortened due to discomfort.Pt's temp is 100.6 md called, order to given vancomycin 1000mg and fortaz 1000mg iv slowly.After bc from catheter, pt weak.Daughter states she will take to er if worse, pt out to car by wc." however, blood cultures taken on the same day showed no growth after 5 days on incubation.The event was considered resolved (b)(6) 2016 and antibiotics were stopped.No action was taken with the study device.
Event or Problem Description
Conclusion of the cec (clinical events committee) following adjudication of the adverse event: infection - no device relationship.

• 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: 6108793
• Report Number: 3008110587-2016-00039
• Device Sequence Number: 18985507
• 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
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 10/01/2016
• Device Model Number: NEXHD1552401
• Device Catalogue Number: NEX HD1552401
• Device Lot Number: 42458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 81