• 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, INC. ENDOMYOCARDIAL BIOPSY FORCEP DEVICE, BIOPSY, ENDOMYOCARDIAL

  • 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, INC. ENDOMYOCARDIAL BIOPSY FORCEP DEVICE, BIOPSY, ENDOMYOCARDIAL Back to Search Results
Model Number 190051
Device Problem Sticking (1597)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 04/11/2017
Event Type  Injury  
Event Description
Patient admitted for cardiac biopsy to rule out amyloidosis. Upon attempt to retrieve tissue sample the endomyocardial biopsy forcep became stuck in the superior vena cava (svc) right atrial junction and failed to open or release despite multiple attempts to open up. Patient was subsequently admitted emergently to the operating room where a sternotomy and small venotomy was completed to remove the biopsy forcep. Manufacturer response for endomyocardia biopsy forcep, endomyocardial biopsy forcep (per site reporter): unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOMYOCARDIAL BIOPSY FORCEP
Type of DeviceDEVICE, BIOPSY, ENDOMYOCARDIAL
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek road
athens TX 75751
MDR Report Key6562757
MDR Text Key75005118
Report Number6562757
Device Sequence Number1
Product Code DWZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 04/30/2017,05/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number190051
Device Catalogue Number190051
Device Lot NumberG14888
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/30/2017
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer04/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 05/12/2017 Patient Sequence Number: 1
Treatment
NO
-
-