MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC LANGSTON V2; DUAL LUMEN CATHETER

Model Number 5540

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

There was no product returned for this complaint.No returned product evaluation could be completed.The manufacturing lot was reviewed and no nonconformances related to this issue was noted, therefore, supporting the device met material, assembly and performance specifications.The account sent an image of the langston catheter.Based off the image, the strain relief had a longitudinal tear.No other damage could be noted.No patient injury or harm was reported.

Event Description

As reported: lumen above the device hub blew out while in use on patient.Additional information received 17aug2020: the patient is doing well.The device was disposed of after the reporting.It did not happen during a power injection.The lumen did not require retrieval or use of a snare.No patient injury reported.

• Brand Name: LANGSTON V2
• Type of Device: DUAL LUMEN CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10448564
• MDR Text Key: 204218661
• Report Number: 2134812-2020-00049
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 30841156100517
• UDI-Public: (01)30841156100517
• Combination Product (y/n): N
• PMA/PMN Number: K051395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 5540
• Device Lot Number: 650873
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0110-2021-Z-0113-2021
• Patient Sequence Number: 1