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

Model Number	5540
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Langston v2 catheter was not returned for evaluation.Investigation is in progress; when results or further information is received a follow-up report will be submitted.
Event or Problem Description
It was reported that the catheter ruptured during an lv gram.The catheter fractured in between the hub and the y port.No further complications were reported.
Additional Manufacturer Narrative
A returned product evaluation was completed and confirmed excess adhesive was present on the inner catheter shaft and likely caused the reported event.The inner catheter shaft was separated just distal to the proximal device hub.The root cause was traced to supplier manufacturing process.

• Brand Name: LANGSTON V2
• Common Device Name: DUEL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9801352
• Report Number: 2134812-2020-00020
• Device Sequence Number: 609698
• Product Code: DQO
• UDI-Device Identifier: 30841156100517
• UDI-Public: (01)30841156100517
• Combination Product (Y/N): N
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 10/24/2021
• Device Model Number: 5540
• Device Lot Number: 660910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1747-2020
• Patient Sequence Number: 1