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

MAUDE Adverse Event Report: REX MEDICAL LP OPTION ELITE RETRIEVABLE VENA CAVA 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
 

REX MEDICAL LP OPTION ELITE RETRIEVABLE VENA CAVA FILTER Back to Search Results
Model Number 352506070E
Event Type  Other  
Event Description

As reported to rex medical via argon product experience report form: during retrieval after sheathing down noticed on leg was outside of sheath. It had fractured at some unidentified time. During retrieval of the leg, it fractured again and two small pieces could not be retrieved as they were incorporated into the cava wall.

 
Manufacturer Narrative

Complaint follow up: request/review case images, videos, etc. To be provided for review. Complaint sample evaluation: complaint sample was not returned to for evaluation. Retain device evaluation: no device retain evaluation performed as no lot number was provided for product complaint. Root cause: a definitive root cause for this product complaint could not be determined due to insufficient info provided to rex medical for investigation. There was no product returned for investigation; there were no case images or videos provided for review. There was no lot number provided for the product complaint so a device history record review could not be performed to check for any manufacturing abnormalities. This product complaint is considered an isolated incident.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOPTION ELITE RETRIEVABLE VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
REX MEDICAL LP
conshohocken PA
Manufacturer (Section G)
MERIT MEDICAL PRODUCTS
65 great valley parkway
malvern PA 19355
Manufacturer Contact
555 north lane, ste 5035
conshohocken , PA 19428
6109400665
MDR Report Key4217388
Report Number3003862657-2014-00007
Device Sequence Number1
Product CodeDTK
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 07/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number352506070E
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/01/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/09/2014 Patient Sequence Number: 1
-
-