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

Catalog Number NEXHD1552401

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Pleural Effusion (2010); Pneumonia (2011)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device (disc only) will be returned for evaluation; therefore an analysis of the complaint device will be completed when returned device is received.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.A root cause will be assigned to this complaint once the investigation is completed.

Event Description

(b)(6): the patient had a nexsite device successfully placed (b)(6) 2016.At the 60-day review on 08 apr 2016, it was reported that the patient had a mild exit site infection on (b)(6) 2016.The old catheter dressing appeared to have some drainage present.Catheter exit site culture showed light growth of staphylococcus epidermidis while in the central venous bloods, no organisms were seen.No action was taken with the study device and no treatment was given for the event.The event had resolved on (b)(6) 2016 and there were no signs of infection.On (b)(6) 2016, moderate sepsis was reported with a possible device relationship and the patient was hospitalised.While no action was taken with the study device, ceftazidime and vancomycin were given to treat the event.There is no apparent source of sepsis.She has a tunnel catheter in the left which certainly could be the source of her infection but there is no indication at the site of insertion.Ct thorax gave the impression of a right lower lobe pneumonia with minimal right pleural effusion.The catheter was removed on (b)(6) 2016 because it was no longer required.During the process of removing the catheter, the removal tab broke off the disc.No patient effect was noted.The catheter was then removed and occlusive dressing applied.This event had resolved on the same date.

Manufacturer Narrative

Sepsis: taking into consideration the evaluation conducted and the details of the complaint, this investigation is 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."broken disc": a secondary root cause of user is applied to this event.A complaint with a most probable root cause classification of user indicates that through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.This root cause is assigned because the engineering investigation concluded that blunt dissection was not solely used during removal of the device.

• Brand Name: NEXSITE STEPPED TIP
• 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: 5684463
• MDR Text Key: 46075125
• Report Number: 3008110587-2016-00022
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 0539152564006
• UDI-Public: (01)0539152564006(17)161001(10)42458
• 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
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: NEXHD1552401
• Device Lot Number: 42458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2015
• 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 Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 52