MAUDE Adverse Event Report: COOK MEDICAL LLC CELECT IVC FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problems Break (1069); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2020

Event Type  Injury  

Event Description

Celect ivc filter found to be multiply fractured, 2 arms broken off, one retained locally but loose in ivc and other in two pieces, both extravascular, one recently seen to move from near ivc to between right kidney and psoas (1 month interval b/ct scans).Intravascular fragment and tip embedded filter removed with forceps.Extravascular fragments left for now.Fda safety report id# (b)(4).

• Brand Name: CELECT IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL LLC ; bloomington IN
• MDR Report Key: 9728788
• MDR Text Key: 180339642
• Report Number: MW5093070
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2020
• 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: 62 YR
• Patient Weight: 122