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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

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ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN Back to Search Results
Catalog Number 384232
Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 04/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation and no images or videos have been provided, so the complaint cannot be confirmed. If additional information is provided in the future, this issue will be reevaluated as needed.
 
Event Description
Argon picc rupture having migrated from it into the patient's heart. Required hemodynamic procedure for withdrawal.
 
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Brand NameFIRST PICC 26GA, SINGLE LUMEN
Type of DeviceFIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key8676770
MDR Text Key147334003
Report Number1625425-2019-00181
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/07/2021
Device Catalogue Number384232
Device Lot Number11218050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/06/2019 Patient Sequence Number: 1
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