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

Catalog Number	NEXHD1552801
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A secondary root cause of not confirmed is assigned as the most probable root cause classification with regards to the reported hole in the catheter.The complaint included a device review (visual, physical and/or performance testing) which showed no evidence of the alleged issue or any defect which could have contributed to the event.Product analysis did not confirm any leaks along the length of the catheter.
Event or Problem Description
(b)(4): the nexsite device was successfully placed on (b)(6) 2016.On (b)(6) 2017, a catheter malfunction presented as having poor blood flows during the dialysis session.The catheter was replaced with another one (not a nexsite hd catheter) and the event resolved on the same date.Subject is now dialysing well with no complications.The procedure note states that there was a fibrin sheath in the brachiocephalic vein in addition to there being a "hole" in the catheter.

• 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: 6383312
• Report Number: 3008110587-2017-00002
• Device Sequence Number: 18963099
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)161101(10)42550
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 42550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLOPURINOL; CARVEDILOL; FUROSEMIDE; GLYBURIDE; LISINOPRIL; NIFEDIPINE; TIROSINT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 68