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 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Langston v2 catheter was not returned for evaluation; however, images were submitted.The investigation is in progress; when results or further information is received a follow-up report will be submitted.

Event Description

As reported, langston catheter was being advanced in the descending aorta and cardiologist was having difficulty advancing, so decided to pull it out and it was split once he saw it out of the body.No fragments needed to be retrieved, catheter came out intact.No power injection was performed.

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: 9853363
• MDR Text Key: 197335157
• Report Number: 2134812-2020-00026
• 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: 02/20/2020

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 5540
• Device Catalogue Number: 5540
• Device Lot Number: 661139
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1747-2020
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 96