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

Model Number	NEXHD1553201
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/10/2016
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.With regards to the skirt position, a secondary root cause of user error is applied to this event.A complaint with a most probable root cause classification of user indicates that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.
Event or Problem Description
Study (b)(6): the nexsite device was successfully placed on (b)(6) 2016 to replace a device (non-nexsite) that had clotted.On (b)(6) 2016, the patient had a fever.He attended the emergency department on (b)(6) 2016.Right upper chest dialysis catheter had some mild swelling.Per the hospital note, the subject's labs showed leukocytosis and no clear source of the infection was identified.There was concern about the catheter being the source of the infection.Vancomycin and gentamacin were given to treat the suspected crbsi and the patient was sent home to be seen at dialysis the next day.When the subject arrived to the access unit on (b)(6) 2016, vascular staff noted that the subject was very lethargic with an elevated temperature.The vascular staff sent the subject to the local emergency department to receive iv antibiotics.When the sub-investigator went to the emergency department to remove the catheter, it was noted that the dacron skirt had separated from the inserted disc.The dacron skirt was outside of the catheter exit site.The patient was admitted to hospital and iv daptomycin was given.The event was resolving.
Event or Problem Description
Database reconciliation of study (b)(6): daptomycin was given to treat the event from (b)(6) 2016.The event had resolved on (b)(6) 2016.
Event or Problem Description
Conclusion of the cec (clinical events committee) following adjudication of the adverse event: crbsi/exit site complications - cannot rule out soft tissue infection involving right upper chest around the insertion site.

• Brand Name: NEXSITE STEPPED TIP
• Common Device Name: HEMODIAYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• MDR Report Key: 5945206
• Report Number: 3008110587-2016-00030
• Device Sequence Number: 11101667
• Product Code: MSD
• UDI-Device Identifier: 05391525640044
• UDI-Public: (01)05391525640044(17)161101(10)42551
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/15/2016

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 Model Number: NEXHD1553201
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 42551
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: 11/02/2017; 06/25/2018
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/06/2017; 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 91