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

Model Number	5540
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found, thus supporting that the device met material, assembly, and performance specifications prior to shipment.One langston pigtail catheter was returned for evaluation.Both lumens were flushed with no resistance.Blood was present inside the proximal y-connector and hub, along with the outer lumen.Both catheter lumens were then blocked, and water was pushed through each lumen separately.No cracks or leaks were identified.No product failure was detected.
Event or Problem Description
Upon aspiration doctor notice air in the distal end of the pigtail.Additional information received 12mar19: the langston was inside the patient and the technician attached a syringe to the hub outside the patient, pulled back to aspirate at which point air was noticed in the catheter line outside the body.To clarify, the air was not observed in the patient's anatomy.

• 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: 8482925
• Report Number: 2134812-2019-00019
• Device Sequence Number: 11193474
• Product Code: DQO
• UDI-Device Identifier: 30841156100517
• UDI-Public: (01)30841156100517(17)210208(10)642178
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial

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: 02/08/2021
• Device Model Number: 5540
• Device Lot Number: 642178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1