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

Catalog Number NEXHD1552801

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2015

Event Type  malfunction  

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 there were no deviations or non-conformances that could 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): the device was placed successfully in the right internal jugular vein on (b)(6) 2015.The patient presented to the access centre on (b)(6) 2015 due to issues of poor flow through the catheter at outpatient dialysis clinic.Poor flow of the arterial port was confirmed; "does not pull" while the venous port "appeared to be working well".2mg of tpa (tissue plasminogen activator) was instilled into both catheter limbs.Medication was allowed to dwell for 30 minutes and then the medication was aspirated.Upon removal of the medication, both ports appeared to have adequate flow.The patient was discharged in a stable condition with a working nexsite catheter.Then on (b)(6) 2015, the patient returned to the access centre again as the dialysis unit reported no flow through the catheter.The flow was inadequate for dialysis and the catheter was removed on (b)(6) 2015.The patient received a non-nexsite catheter and was discharged in a stable condition.The event was considered resolved on this date.

• 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: 5139915
• MDR Text Key: 28381008
• Report Number: 3008110587-2015-00016
• 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: health professional,study
• Reporter Occupation: Nurse
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2016
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 39413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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 Age: 71 YR
• Patient Weight: 93