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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 3.2FR
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ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 3.2FR Back to Search Results
Model Number 381003008
Device Problems Failure to Advance (2524); Mechanical Jam (2983)
Patient Problem Insufficient Information (4580)
Event Date 10/27/2021
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been reviewed.
 
Event Description
During use, the physician attempted to insert the snare into the delivery catheter with using the introducer, however, the snare got stucked and unable to advance.Then the physician attempted to insert the snare to the delivery catheter from the distal tip of the delivery catheter, but the snare got stucked again.Unable to set the snare in the delivery catheter.The atrieve was switched to another new one and the procedure was completed.
 
Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been investigated.A follow-up report will be provided once the device has been investigated and reviewed.
 
Event Description
During use, the physician attempted to insert the snare into the delivery catheter with using the introducer, however, the snare got stucked and unable to advance.Then the physician attempted to insert the snare to the delivery catheter from the distal tip of the delivery catheter, but the snare got stucked again.Unable to set the snare in the delivery catheter.The atrieve was switched to another new one and the procedure was completed.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One unsealed atrieve was returned for review by the customer.A visual and dimensional inspection was performed on the returned product.The visual inspection established that there was no external damage found on the device during the investigation.The part was measured on several places such as the proximal, middle, distal, taper, and solder.The measurements were within specification according to drawings.With only the atrieve returned the delivery catheter sheathe cannot be checked for any defects.Since there was no issue observed during the investigation, no corrective action will be done at this time.
 
Event Description
During use, the physician attempted to insert the snare into the delivery catheter with using the introducer, however, the snare got stucked and unable to advance.Then the physician attempted to insert the snare to the delivery catheter from the distal tip of the delivery catheter, but the snare got stucked again.Unable to set the snare in the delivery catheter.The atrieve was switched to another new one and the procedure was completed.
 
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Brand Name
ATRIEVE VASCULAR SNARE KIT 3.2FR
Type of Device
ATRIEVE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12965712
MDR Text Key283482817
Report Number0001625425-2021-01208
Device Sequence Number1
Product Code MMX
UDI-Device Identifier20886333003963
UDI-Public20886333003963
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021606
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/19/2022
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 Number381003008
Device Catalogue Number381003008
Device Lot Number11351925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2021
Initial Date FDA Received12/08/2021
Supplement Dates Manufacturer Received11/30/2021
11/30/2021
Supplement Dates FDA Received01/04/2022
05/20/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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