MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. LANGSTON DUAL LUMEN CATHETER

Model Number 5540

Device Problems Nonstandard Device (1420); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

A langston catheter was used during a patient procedure.Upon pressure injection, the inner shaft of the langston catheter separated.The catheter was retrieved successfully and no patient impact was reported.

Manufacturer Narrative

Submission of this report does not represent a conclusion or admission by vascular solutions, inc.That the content of the report is complete or accurate, that the device failed or malfunctioned in any manner, or that the device caused or contributed to a death.

Manufacturer Narrative

(b)(4).

• Brand Name: LANGSTON DUAL LUMEN CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• Manufacturer Contact: renee runtsch ; 6464 sycamore court north; maple grove, MN 55369 ; 7636564366
• MDR Report Key: 3863844
• MDR Text Key: 18362708
• Report Number: 2134812-2014-00019
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/16/2014

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: 02/29/2016
• Device Model Number: 5540
• Device Lot Number: 570927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 06/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Removal/Correction Number: 2134812-05/23/2014-01R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention