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

Catalog Number NEXHD1555501

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/20/2015

Event Type  Injury  

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 and no deviations that could affect product quality were found.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 ns 001: the nexsite device was successfully placed on (b)(6) 2015 in the right femoral vein.The catheter was removed on (b)(6) 2015 for a bacteremia event.Blood cultures collected on (b)(6) 2015 and reported on (b)(6) 2015 were positive for (b)(6).She is now afebrile on intravenous vancomycin.The catheter, cuff and disc were all normal on removal.The only significant issue was odor at the exit site.She was not hospitalised for this event." i was a little surprised that the cuff had rubbed the skin raw.Patient is apparently transitioning to pd (peritoneal dialysis).She has run out of good av access sites.I put in a left femoral tdc ( not a nexsite) today to use until she starts pd.She is a very large woman and did well in my opinion with the nexsite catheter in the femoral position from feb until now".

• 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: 5093415
• MDR Text Key: 26355698
• Report Number: 3008110587-2015-00014
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Report Date: 08/26/2015

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: 03/31/2015
• Device Catalogue Number: NEXHD1555501
• Device Lot Number: 36283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Date Device Manufactured: 04/10/2014
• 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): Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 162