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

Catalog Number NEXHD1552801

Device Problems Obstruction of Flow (2423); Aspiration Issue (2883)

Patient Problems Bacterial Infection (1735); Stroke/CVA (1770); Confusion/ Disorientation (2553)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Study (b)(4): patient is demented and in a nursing home.She has a history of numerous catheter exchanges due to fibrin sheath.She is catheter dependent."i placed new rij (right internal jugular) nexsite catheter on (b)(6) 2015".On (b)(6) 2015, patient was admitted for stroke symptoms at the dialysis unit.A head ct was negative for anything acute.In the hospital, she had a fever with an existing right ij catheter "nextstep".Dialysis unit called on (b)(6) 2015 and said that catheter would not pull/aspirate.They tried tpa (tissue plasminogen activator) but it did not dissolve clots in tip of the catheter.The catheter was removed and the patient was loaded with vancomycin and gentamicin.She was afebrile and had one single blood culture positive for coag-negative staph.Single isolates of this organism are of questionable clinical significance.Catheter tip culture was also showed "very light" contamination with coag-negative staph.She was treated with vancomycin once culture was known."she was not unstable or septic.This was in no way related to her reason for admission which was the stroke".A temporary catheter was placed and was exchanged to a permanent catheter via interventional radiology."i elected not to put another nexsite today because i fear she forms clots and fibrin sheaths no matter what catheter".Blood cultures were repeated on (b)(6) 2015, and there was no growth after seven days of incubation.The patient has no history of strokes but all esrd patients have higher history of vascular events.The ct head on (b)(6) 2015 showed a "large, evolving, acute stroke in the left parieto-occipital brain".Discharge summary showed possible cva (cerebrovascular accident), coag neg staph bacteremia from line infection, confusion relating to cva and bacteremia.The patient was discharged back to her nursing home on (b)(6) 2015 with minimal deficits.Her last dose of vancomycin was to be given as an outpatient on (b)(6) 2015.

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 confirms that the lot met the specification requirements.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.

Manufacturer Narrative

The physician confirmed on (b)(6) 2015 that the device involved was inserted on (b)(6) 2014 (not (b)(6) 2015 as reported in the initial mdr) and removed on (b)(6) 2015 in the hospital because of bacteremia episode.No other nexsite catheters were placed in this patient.Therefore, this patient had one nexsite device that was in place for 127 days.

• 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: 4725752
• MDR Text Key: 18291225
• Report Number: 3008110587-2015-00004
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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: NEXHD1552801
• Device Lot Number: 36284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2014
• 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
• Treatment: CARVEDILOL (COREG); PRAVASTATIN (PRAVACHOL); TRAMADOL; DOCUSATE SODIUM (COLACE); CALCIUM ACETATE (PHOSLO); ACETAMINOPHEN (TYLENOL); ASPIRIN; B COMPLEX; SIMETHICONE; OMEPRAZOLE (PRILOSEC); IOSARTAN (COZAAR); AMLODIPINE (NORVASC)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 57