Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ATRIEVE VASCULAR SNARE KIT 7FR
  • 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 ATRIEVE VASCULAR SNARE KIT 7FR Back to Search Results
Model Number 382007030
Device Problems Break (1069); Material Frayed (1262); Unraveled Material (1664)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as available for evaluation.As of the date of this report, it has not yet been returned.A follow-up report will be submitted once the sample has been received and reviewed.
 
Event Description
Atrieve snare being used for filter removal.One of the snare loops that is wrapped with the thin wire around the loop looked to break or begin to unwind.Doctor not sure if he caught the loop on a sharp area of the filter when pulling to retrieve.Team able to retrieve filter as well as the small piece that was frayed off through the sheath.
 
Event Description
Follow up.
 
Manufacturer Narrative
H3 other text: placeholder.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATRIEVE VASCULAR SNARE KIT 7FR
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key11520662
MDR Text Key242907742
Report Number1625425-2021-00876
Device Sequence Number1
Product Code MMX
UDI-Device Identifier20886333003994
UDI-Public20886333003994
Combination Product (y/n)N
PMA/PMN Number
K021606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number382007030
Device Catalogue Number382007030
Device Lot Number11343855
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/18/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-