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

Model Number	5550
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
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.Several samples of the same lot were returned to manufacturer for investigation from the site.A follow-up report will be submitted when completed.
Event or Problem Description
The internal and external catheter became detached at the hub.Additional information received 05/13/2019: there was nothing unusual about the handling and no pressure injection was done on this case.We were attempting to cross a severely stenosed valve and it took about 30 minutes.The catheter separation was noticed at the middle of the case when we tried to flush the lumens with the manifold, only manual flush of the sidearm was done, it was then we noticed bubbles as we drew back on the tubing to purge the line.We also noticed that saline was dripping by the connection.A different langston catheter was used successfully to complete the procedure.No medical intervention was required.
Additional Manufacturer Narrative
The account requested to send back unused units from the same lot, and those units were evaluated.A visual inspection and leak testing were completed, and no issues were found.Without evaluating the device in question, it is undeterminable what caused the event.

• 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: 8690915
• Report Number: 2134812-2019-00041
• Device Sequence Number: 2005986
• Product Code: DQO
• UDI-Device Identifier: M20655501
• UDI-Public: M20655501
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/13/2019

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: 06/12/2020
• Device Model Number: 5550
• Device Lot Number: 627609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 82