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	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Langston v2 catheter was returned for evaluation.A manufacturing record review was completed and zero nonconformances were found therefore supporting that the device met material, assembly and performance specifications.Catheter was sent out to the supplier for investigation.When information is received a follow-up report will be submitted.
Event or Problem Description
Catheter split near the hub after power injection.900psi 24 for 12.No patient injury or impact reported.
Additional Manufacturer Narrative
Supplier attempted to recreate the defect to determine if excessive glue may have been the root cause of the catheter rupture.Thirty test units were created and tested per current testing processes for burst pressure.At this time, between the visual examination of the returned unit and the testing of replicate units, we are unable to establish a definite root cause.If further information is received a follow-up report will be submitted.

• Brand Name: LANGSTON V2
• Common Device Name: DUEL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8994935
• Report Number: 2134812-2019-00063
• Device Sequence Number: 16989243
• Product Code: DQO
• UDI-Device Identifier: 10841156100513
• UDI-Public: (01)10841156100513
• 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,Followup
• Report Date (Section B): 08/15/2019

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: 06/17/2021
• Device Model Number: 5540
• Device Catalogue Number: 5540
• Device Lot Number: 651278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1