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

Model Number	5540
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing record review was completed and no nonconformances related to this lot were found therefore supporting the device met material, assembly and performance specifications prior to shipment.Cured adhesive fillet was present all around the luer, suggesting that the manufacturing process was followed correctly.However, the proximal most bond between the strain relief and hub failed.There was no separation of the catheter.The entire outer lumen was removed from the catheter to expose the inner lumen.There was no damage to the inner lumen when examined under a microscope.Cause cannot be established.
Event or Problem Description
There was air leakage at proximal end of catheter.The procedure being performed was a right and left heart cath.The device was inspected prior use and there was no visual damage to the hub.All the fittings checked were secure so that air would not be introduced into the catheter during use and rechecked several times.The catheter was flushed prior to use.There was no adverse impact on the patient.

• Brand Name: LANGSTON V2
• Common Device Name: DUAL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8830760
• Report Number: 2134812-2019-00051
• Device Sequence Number: 19586147
• Product Code: DQO
• UDI-Device Identifier: 10841156100513
• UDI-Public: 10841156100513
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K051395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: 5540
• Device Lot Number: 642031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR