MAUDE Adverse Event Report: CARDINAL HEALTH/ CORDIS US CORP. CORDIS OPTEASE RETRIEVABLE IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problems Nonstandard Device (1420); Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2011

Event Type  Injury  

Event Description

I found out online (b)(6) 2021 that my medical device cordis optease ivc filter was recalled back in 2013.No notification from hospital, or manufacturer.After examining my hospital records, i have found that the fda class 1 recalled device is inside my body.Not only is it inside my body, the trauma surgeon who placed the device inside of me, placed it backwards according to the recalled instructions.I have the vascular surgeon who tried twice to remove the backwards ivc filter states that it is backwards.Fda safety report id# (b)(4).

• Brand Name: CORDIS OPTEASE RETRIEVABLE IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CARDINAL HEALTH/ CORDIS US CORP.
• MDR Report Key: 13283723
• MDR Text Key: 284149776
• Report Number: MW5106714
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/01/2013
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15193960
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID ; CALCIUM; MAGNESIUM; MULTI VITAMIN ; UNITHROID; VIT D
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White