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

Catalog Number	NEXHD1553201
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	06/01/2016
Type of Reportable Event	Malfunction
Additional 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 the lot met the specification requirements.The review 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 or Problem Description
(b)(4): the nexsite device was successfully placed on (b)(6) 2016.On (b)(6) 2016, moderate positional related flow issues occurred.Cathflo activase was given to treat the event.The patient also experienced chest pain radiating to right arm on (b)(6) 2016 and was hospitalised for this event to rule out myocardial infarction.A cardiac echo was completed on (b)(6) 2016.Subject had three sets of cardaic enzymes that were negative.A chest x-ray showed an infiltrate in the right base.The note states that this was covered with antibiotics given her recent hospital admissions.The hospital note also states that the right chest dialysis access catheter site appeared healthy.Levaquin, linodil and zosyn were given to treat this hospital-acquired infection.The patient was discharged on (b)(6) 2016 and the chest pain event had fully resolved.This event was unrelated to the study device.The device was removed on (b)(6) 2016 due to positional related flow issues.The event had fully resolved.

• Brand Name: NEXSITE HD STEPPED TIP
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• MDR Report Key: 5768492
• Report Number: 3008110587-2016-00027
• Device Sequence Number: 636315
• Product Code: MSD
• UDI-Device Identifier: 05391525640068
• UDI-Public: (01)05391525640068(17)161101(10)42551
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: NEXHD1553201
• Device Lot Number: 42551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 68