MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. LANGSTON DUAL LUMEN CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTICCATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 5550

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 09/07/2016

Event Type  malfunction  

Event Description

According to the doctor, both lumens of the catheter were "plugged up" which he realized once the catheter was inside the patient and he tried to flush the lumens.

• Brand Name: LANGSTON DUAL LUMEN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTICCATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore ct n; maple grove MN 55369
• MDR Report Key: 6030489
• MDR Text Key: 57483685
• Report Number: 6030489
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5550
• Device Lot Number: 587915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2016
• Event Location: Other
• Date Report to Manufacturer: 09/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR