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

Model Number 5540

Device Problem Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2019

Event Type  malfunction  

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 Description

Catheter split near the hub after power injection.900psi 24 for 12.No patient injury or impact reported.

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
• Type of Device: DUEL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8994935
• MDR Text Key: 193761034
• Report Number: 2134812-2019-00063
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10841156100513
• UDI-Public: (01)10841156100513
• Combination Product (y/n): N
• PMA/PMN Number: K051395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1