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 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

Langston v2 catheter was returned for evaluation.Investigation is in progress; when results or further information is received a follow-up report will be submitted.

Event Description

It was reported that an angiogram viewed on a social media private group showed an issue with a langston dual lumen catheter during use.The video depicted a langston catheter being used for an lv-gram; soon after contrast began to exit the distal tip, the inner catheter appears to separate and bunch up outside the distal tip of the rest of the catheter.Follow up with the social media contact and personnel with the customer confirmed the patient remained stable and the separated piece of the catheter was snared and removed.No further complications were reported.

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
• Type of Device: DUEL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9795032
• MDR Text Key: 193063814
• Report Number: 2134812-2020-00019
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 1084115600513
• UDI-Public: (01)1084115600513
• Combination Product (y/n): N
• PMA/PMN Number: K051395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: 5540
• Device Lot Number: 660397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 02/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1747-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention