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

Catalog Number	NEXHD1555501
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812)
Date of Event	03/22/2016
Type of Reportable Event	Serious Injury
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
Study (b)(6): the nexsite device was successfully placed on (b)(6) 2016 in the right femoral vein.This (b)(6) old female had no issues until (b)(6) 2016 when rn found yellow exudate at catheter exit site while changing dressing.Patient had no complaints of fever or chills, no abnormal vital signs.Patient denied drainage at exit site previous to rn assessment.Access running well.Exit site culture taken on (b)(6) 2016.Staph epidermidis positive culture result on (b)(6) 2016.Patient started on vanco 1000mg iv qhd per sensitivity report and sent to rac for nexsite removal.Patient seen at rac on (b)(6) 2016.Per rac report, purulent drainage noted at exit site as well as abscess.Catheter removed.New right femoral cannon catheter was placed.Patient remains pc dependent as no other options for avg/avf or hero.There were no blood cultures drawn as assessment benign with exception of exit site exudate.Patient has not been hospitalized recently, nor has she had any positive blood cultures.Last culture drawn in center (b)(6) 2015 which was negative for growth.

• Brand Name: NEXSITE STEPPED TIP
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre,; gmit, dublin road,; galway, ; EI
• MDR Report Key: 5619119
• Report Number: 3008110587-2016-00016
• Device Sequence Number: 16218006
• Product Code: MSD
• UDI-Device Identifier: 05391525640105
• UDI-Public: (01)05391525640105(17)161001(10)42457
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140492
• 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): 04/07/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/10/2016
• Device Catalogue Number: NEXHD1555501
• Device Lot Number: 42457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 04/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 54