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

Model Number 5540

Device Problem Separation Problem (4043)

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

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: cut down axillary tavr.Used the langston in the right radial artery instead of getting any groin artery access.We got radial access to use a langston for injections and pressures.We took one injection of the ao.We went to reposition the catheter with the j tip wire.The physician realized the wire was not coming out of the pigtail of the catheter.The catheter was removed from the arm via over the wire.When catheter was pulled out the inner lumen was still in the arm.All of langston was removed with no injury or issues.

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
• Type of Device: DUEL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9856735
• MDR Text Key: 188825747
• Report Number: 2134812-2020-00027
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2021
• Device Model Number: 5540
• Device Catalogue Number: 5540
• Device Lot Number: 655128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 03/04/2020
• 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
• Patient Age: 73 YR
• Patient Weight: 59