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

Lot Number 575260

Device Problems Kinked (1339); Unable to Obtain Readings (1516); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

Catheter was found to be kinked and defective, and unable to obtain the accurate pressure readings.A new catheter opened and worked without problems.

• Brand Name: LANGSTON DUAL LUMEN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court; maple grove MN 55369
• MDR Report Key: 4435954
• MDR Text Key: 5371997
• Report Number: 4435954
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 575260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR