• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEANER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARGON MEDICAL DEVICES CLEANER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
The incident was mentioned in a cirse 2016 conference, and was not a complaint reported to argon. It was discovered during a clinical literature search. There is no contact for the incident to be investigated further.
 
Event Description
Found during a clinical literature search for an update of the cleaner cer (cer-0007 rev c, released july 9, 2020): abstract p-651 of the abstract and article index for the cirse 2016 conference held september 10-14, 2016, in barcelona, spain. "acute pulmonary embolism complicating upper extremity thrombolysis with cleaner, a rotational thrombectomy device" by n. B. Mani, a. J. Gunn, r. Ramaswamy, m. D. Darcy of the division of interventional radiology, mallinckrodt institute of radiology, washington university in st. Louis school of medicine, st. Louis, mo, united states of america. We present a case of acute pulmonary embolism causing acute cardiorespiratory arrest following the use of cleaner (a rotational thrombectomy device) while attempting to clear thrombus during an upper extremity lysis in a patient with history of non-small cell lung cancer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCLEANER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10294929
MDR Text Key199494255
Report Number1625425-2020-00426
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
PMA/PMN Number
D258712
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Remedial Action Other
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/20/2020 Patient Sequence Number: 1
-
-