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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LANGSTON V2; DUAL LUMEN
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LANGSTON V2; DUAL LUMEN Back to Search Results
Model Number 5550
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
Langston v2 catheter was returned for evaluation.When internal investigation is complete, a follow-up report will be submitted.
 
Event Description
It was reported: during diagnostic for a tavr work up, which there was aortic stenosis, they pulled the langston out of the body, the inner and outer catheter lumen was noted to separate, however, no further complications were reported.Unable to obtain actual lot number to reported event.
 
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.
 
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Brand Name
LANGSTON V2
Type of Device
DUAL LUMEN
MDR Report Key10329383
MDR Text Key205351828
Report Number2134812-2020-00042
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K051395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0110-2021- Z-0113-2021
Patient Sequence Number1
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