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

Catalog Number NEXHD1552801

Device Problem Improper Flow or Infusion (2954)

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

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation because the device remains in situ; therefore, an analysis of the complaint device could not be completed.A manufacturing documentation review that the lot met specification requirements and found 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

(b)(4): this patient had a nexsite device placed on (b)(6) 2015 in the right internal jugular vein.On (b)(6) 2015, the patient had mild reduced blood flow.No action was taken with the study device.Cathflo medication was given and the event resolved.

Manufacturer Narrative

Device manufacture date added.

Event Description

(b)(4).On (b)(6) 2015.The patient had moderate reduced blood flow and the nexsite catheter was removed and exchanged for another device.The event resolved on the same date.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.

• 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: 5031809
• MDR Text Key: 25115680
• Report Number: 3008110587-2015-00008
• 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
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• 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?: No
• Date Manufacturer Received: 09/15/2015
• 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: 41 YR
• Patient Weight: 110