MAUDE Adverse Event Report: WILLIAM COOK EUROPE APS CELECT PLATINUM IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  Injury  

Event Description

Celect platinum ivc filter found to be fractured with filter arm loose in right renal vein.Free mobile fragment was removed with forceps and filter removed with forceps.

• Brand Name: CELECT PLATINUM IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE APS
• MDR Report Key: 7709891
• MDR Text Key: 114847614
• Report Number: MW5078507
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 107