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

Model Number NEXHD1552801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Hematoma (1884); Post Operative Wound Infection (2446)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation because the device remains implanted 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.The manufacturer has requested additional information regarding the incident.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 Description

(b)(4): this patient had her nexsite device placed successfully on (b)(6) 2016.Upon the subject's arrival to dialysis on (b)(6) 2016, the dialysis staff noted an open wound and drainage from the catheter exit site.The rounding doctor was notified and they ordered blood and wound cultures.The blood results came back on (b)(6) 2016 with zero growth.The results from the wound culture came back (b)(6) 2016 and showed enterobacter clocae complex having heavy growth.The subject was started on ceftazidime 200mg iv on (b)(6) 2016.The antibiotic was given due to positive bacteria growth/infection from the wound culture.Per the rn at the dialysis center, a mild hematoma developed near the catheter site on (b)(6) 2016.No treatment was given for this event and the hematoma was resolving.The (b)(6) 2016, the drainage at the exit site was resolving.No action was taken with the study device.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation because the device has been disposed.

Event Description

Follow-up information received: wound/drainage culture on (b)(6) 2016 showed enterobacter clocae complex.The patient had her catheter removed on (b)(6) 2016 due to infected disc pocket/drainage and exposed disc.The drainage may have been a result of the hematoma rupturing.Ceftazidime was given to treat the infection.Two sets of blood cultures on (b)(6) 2016 showed no growth.

Event Description

Additional information provided by monthly site monitoring visit indicated that the drainage at the exit site had resolved on (b)(6) 2016, the hematoma had resolved on (b)(6) 2016, and the infected disc pocket/exposed disc had resolved on (b)(6) 2016.It was also noted the vancomycin and ceftazidime were given as treatments for the infection on (b)(6) 2016 and vancomycin was given again on (b)(6) 2016.

• 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: 5466798
• MDR Text Key: 39257034
• Report Number: 3008110587-2016-00009
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)160301(10)40161
• 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,Followup
• Report Date: 02/22/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2016
• Device Model Number: NEXHD1552801
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 40161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided; 08/15/2017
• Supplement Dates FDA Received: 04/07/2016; 08/31/2017
• Date Device Manufactured: 03/12/2015
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 85