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

MAUDE Adverse Event Report: B. BRAUN MEDICAL SAS LP VENATECH FILTER

  • 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
 

B. BRAUN MEDICAL SAS LP VENATECH FILTER Back to Search Results
Model Number 31335
Device Problems Migration or Expulsion of Device (1395); Migration (4003)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/20/2016
Event Type  Injury  
Event Description

Filter was implanted in patient (b)(6) 2011 and migrated into the heart. The patient had surgery to remove the filter. On (b)(6) 2016 patient underwent an echocardiogram of the chest which demonstrated that the filter had migrated in its entirety to the heart. On (b)(6) 2016 patient underwent an x-ray of the chest that confirmed the entire filter had migrated into the right atrium. On (b)(6) 2016 the patient underwent consultation with physicians who stated the filter is in the right atrium with the head oriented toward the ivc and the prongs facing toward the svc in disarray thus making percutaneous removal impossible. Patient underwent open sternotomy to remove the filter. During the removal the filter was in the right atrium with the apex in the coronary sinus and two struts of the filter were penetrating the anterior and septal tricuspid valve leaflets, requiring repair of the tricuspid valve.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLP VENATECH FILTER
Type of DeviceVENATECH FILTER
Manufacturer (Section D)
B. BRAUN MEDICAL SAS
26 rue armengaud
saint-cloud 92210
FR 92210
MDR Report Key10132656
MDR Text Key198140065
Report Number3006332832-2020-00006
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 06/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number31335
Device Catalogue Number5010024
Device LOT NumberK055341V
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2020
Distributor Facility Aware Date05/21/2020
Event Location Hospital
Date Report TO Manufacturer05/21/2020
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/09/2020 Patient Sequence Number: 1
-
-