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

Catalog Number NEXHD1555501

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Fever (1858); Inflammation (1932); Pain (1994); Staphylococcus Aureus (2058)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation because the device was removed at a local hospital and was 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.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.It is also noted that the disc was not removed from the patient which is contrary to the dfu.

Event Description

(b)(4): this (b)(6) female patient had a nexsite device placed in the right femoral vein on (b)(6) 2015.The catheter was exchanged with a non-nexsite catheter over a wire at a local hospital due to "dysfunctional catheter" on (b)(6) 2015.There were no specifics as to whether they couldn't aspirate or if it was an inadequate blood flow.There was no record of disc removal.The patient was admitted on (b)(6) 2015 with positive bloods ((b)(6)), pain in right lower extremity and fevers.A ct of the right lower extremity showed a curvilinear foreign body, suspected to be and eventually confirmed as retained disc from study catheter in the right upper anterior thigh.Also adjacent fluid collection and adenopathy with overlying skin inflammation.The catheter was removed at bedside on (b)(6) 2015.Vascular surgeon did incision and drainage on (b)(6) 2015 and removed the disc.The patient was initially placed on vancomycin and zosyn and this was changed to vancomycin only and continued until (b)(6) 2015.Follow up cultures were negative prior to discharge from hospital.A tunnelled dialysis catheter was placed in left femoral.The current condition of the patient is stable.

• Brand Name: NEXSITE STEPPED TIP
• 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: 5225263
• MDR Text Key: 31578048
• Report Number: 3008110587-2015-00018
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 05391525640105
• UDI-Public: (01)05391525640105(17)160201(10)39791
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2015

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/02/2016
• Device Catalogue Number: NEXHD1555501
• Device Lot Number: 39791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/16/2015
• Date Device Manufactured: 02/10/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 68