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

Catalog Number	NEXHD1552801
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device remains implanted; therefore an analysis of the complaint device could not be completed.Because of this, it is not possible to definitively identify the root cause.A thorough review has been completed at the manufacturing facility.No issues were noted during the manufacture that could have contributed to this defect, the manufacture was completed by trained personnel and there have been no incidences of a similar defect since commencement of production of this product.However, trials were completed which have shown that the defect could have occurred if inadequate quantity of adhesive is used.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of manufacturing.A complaint with a most probable root cause classification of manufacturing indicates a complaint in which the product fails to meet specification due to the manufacturing process.Corrective and preventive action capa (b)(4) was initiated to investigate this issue.A secondary root cause of user is also assigned to this complaint because the physician did not adhere to the dfu.Warnings were not adhered to because the device was used despite noting the mechanical damage.Additionally, a wound adhesive was used to bond the cuff to the catheter and adhesive was placed circumferentially at either end of the cuff.
Event or Problem Description
Study (b)(6): during placement of this nexsite device on (b)(6) 2016, the cuff displaced from the catheter.Further details provided indicated that the catheter cuff was moving on the catheter shaft in the direction of the bifurcation joint.The doctor did not have the option of replacing the catheter because this catheter length was not in stock.The doctor indicated that he used a tissue glue for wound healing (cyanoacrylate) to bond the cuff to the catheter and placed adhesive circumferentially at either end of the cuff.He indicated that this gave a good bond and enabled him to position the catheter in the disc as per the placement directions in the dfu.

• Brand Name: NEXSITE HD STEPPED
• 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: 6137581
• Report Number: 3008110587-2016-00040
• Device Sequence Number: 10959131
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)161101(10)42550
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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
• Operator of Device: Physician
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 42550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 12/01/2016
• 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: 34 YR
• Patient Weight: 98