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

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/14/2019

Event Type  Injury  

Event Description

Celect ivc filter found to be fractured, with one arm broken off and retained within the filter.Tip was also embedded.Pt had a failed prior attempt at retrieval.Filter was removed with forceps, as was fragment.Fda safety report id# (b)(4).

• Brand Name: CELECT
• Type of Device: IVC FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL ; bloomington IN
• MDR Report Key: 9335010
• MDR Text Key: 166948718
• Report Number: MW5091128
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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
• 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: 59 YR
• Patient Weight: 88