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

Catalog Number NEXHD1553201

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

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

Event Date 05/05/2015

Event Type  malfunction  

Event Description

(b)(4): the dialysis clinic reported low flow and malfunction on (b)(6) 2015 and the patient had his catheter removed on the same day.The nexsite catheter was removed uneventfully.A new catheter was placed and he is stable clinically with the new catheter.The physician thinks the problem was the left sided placement and catheters frequently do not work as well from the left side because of the extra angles in the catheter course.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation because the device has been discarded; 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.It is also noted that the device was used past its expiry date which is contrary to the dfu.

Event Description

Additional information provided by electronic database provider included past medical history and patient's weight.

• 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: 4794300
• MDR Text Key: 5881939
• Report Number: 3008110587-2015-00005
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 36286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 90