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

Model Number 5540

Device Problem Flushing Problem (1252)

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

Event Date 10/03/2016

Event Type  malfunction  

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.

Event Description

A langston dual lumen catheter was used in a patient procedure.The side holes in one of the lumens would not flush.

Manufacturer Narrative

One catheter model 5540 langston v2, 6f was returned to vsi for evaluation.A returned product evaluation was completed along with a manufacturing record review to determine the most likely root cause for this event.The results of the returned product evaluation were; both lumens of the catheter were flushed with no resistance.A guidewire was passed through the device with no resistance.The side holes on the catheter shaft were free of any debris or blockage.The manufacturing record review determined that there were no nonconformances.The evidence gained throughout this investigation show that no product failure was detected.

• Brand Name: LANGSTON V2
• Type of Device: DUAL LUMEN CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: jacob schultz ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 6075386
• MDR Text Key: 59455344
• Report Number: 2134812-2016-00076
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

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: 01/11/2018
• Device Model Number: 5540
• Device Lot Number: 590558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization