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

Catalog Number NEXHD1552801

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

We are awaiting the returned device so that an evaluation can be completed.A supplemental report will be filed with a root cause classification and codes once the analysis is complete.

Event Description

(b)(6): during the tunneling process of the device placement , the cuff came loose.The cuff was not attached to the catheter very well, and would move when the catheter moved.No patient was injured.The device was not implanted.The physician opened another catheter to complete the procedure.

Manufacturer Narrative

Device evaluation was completed on the returned device and a thorough review has been completed at the manufacturing facility.Taking into consideration the evaluation conducted and the details of the complaint, this investigation is assigned the most probable root cause of manufacturing.A complaint with a most probable root cause classification of manufacturing indicates the product fails to meet specification due to the manufacturing process.Corrective and preventive action capa (b)(4) was updated to include this issue.

Event Description

Device analysis was completed on the returned catheter.An attempt was made to move the cuff from the proximal end and no movement was evident.An attempt was made to move the cuff from the distal end and it was noted that the barbell moved and the cuff accordioned (bunched up) when force was applied.It was noteworthy that the bunching stopped halfway up the cuff.This can be explained by enough adhesive on the proximal portion of the barbell to bond it firmly to the catheter but not enough adhesive on the distal end of the barbell.

• Brand Name: NEXSITE HD STEP TIP
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• Manufacturer Contact: fiona geraghty ; innovation in business centre; gmit, dublin road; galway, H91 D-CH9 ; EI H91 DCH9
• MDR Report Key: 6517868
• MDR Text Key: 73808118
• Report Number: 3008110587-2017-00004
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 0539155640020
• UDI-Public: (01)0539155640020(17)170401(10)43967
• 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: distributor,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/04/2017
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 43967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2016
• 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 Age: 64 YR
• Patient Weight: 118