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

Catalog Number NEXHD1553201

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058)

Event Date 07/03/2015

Event Type  Death  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirmed that there were 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 Description

Study (b)(4): this nexsite device was implanted successfully on (b)(6) 2015.The physician documented that the patient had a negative blood culture before placement.On (b)(6) 2015, the patient had blood cultures drawn for surveillance.The blood cultures were (b)(6) for (b)(6) infection and it was reported that the patient had relapsing catheter associated (b)(6) bacteremia.The patient was afebrile and asymptomatic.The patient was started on vancomycin on (b)(6) 2015 and continued until (b)(6) 2015.He had also been given daptomycin as an outpatient.The patient had negative blood cultures on (b)(6) 2015.Blood cultures drawn in dialysis on (b)(6) 2015 and again on (b)(6) 2015 were (b)(6) for (b)(6).Due to degree of anaemia, hypoalbuminemia and (b)(6) blood cultures, the patient was admitted to hospital on (b)(6) 2015 for evaluation and treatment of catheter-related bloodstream infection.The catheter was removed on (b)(6) 2015 and vancomycin was given.Infectious disease consultant wanted the catheter removed and suspected he seeded his blood from an unknown source, so this was a "bystander / collateral damage " situation.It was felt that patient had developed a bloodstream infection due to possible active infection elsewhere in body.They are looking at his bones, heart valves, old grafts for source.Cultures on (b)(6) 2015 was negative.On (b)(6) 2015, rifampin was added to antibiotic regimen.The plan on (b)(6) 2015 was for 8 weeks of antibiotics.On (b)(6) 2015, the inpatient nephrology note states that the patient "looks well" and hopeful for discharge that week.The patient had a history of (b)(6) from (b)(6) 2013.In (b)(6) 2015, the patient had a right arm avg (arteriovenous graft) removed as cultures were (b)(6) for (b)(6).Tranesophageal echocardiogram did not show any vegetations and blood cultures ultimately turned negative.Antibiotics were completed in (b)(6) 2015.Cultures in (b)(6) 2015 were all "(b)(6)".The patient had ongoing (b)(6) for 4 months despite extended courses of iv vancomycin and hd catheter exchanges.

Manufacturer Narrative

Taking into consideration the evaluation conducted and the details of the complaint, this investigation is assigned the most probable root cause classification of caused by other.The investigation indicates device/drug/procedure/illness/co-morbidity caused the complaint event.This patient had relapsing (b)(6).

Event Description

The site reported that there were no cultures that were (b)(6) prior to device placement.The only outlier is a culture on (b)(6) 2015 where set 1 of 2 was (b)(6) and set 2 of 2 (same date) has no growth.Other than that, he had a history of relapsing (b)(6).He has since passed away.

Event Description

Additional information received from electronic database provider indicated the date of death as (b)(6) 2015.It is noted that the patient completed the study on (b)(6) 2015.

• Brand Name: NEXSITE STEPPED
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre,; gmit, dublin road,; galway, ; EI
• Manufacturer Contact: fiona geraghty ; innovation in business centre; gmit, dublin road,; galway, ; EI ; 91759301
• MDR Report Key: 5053044
• MDR Text Key: 24920475
• Report Number: 3008110587-2015-00009
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 05391525640044
• UDI-Public: (01)05391525640044(17)160101(10)39352
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/05/2015

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
• Device Operator: Physician
• Device Expiration Date: 01/01/2016
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 39352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/18/2016; 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 76