MAUDE Adverse Event Report: COOK, INC. COOK IVC FILTER RETRIEVAL SET TULIP; DEVICE, PERCUTANEOUS RETRIEVAL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

During ivc filter retrieval, posterior end of shaft of the snare in cook gunther tulip ivc filter retrieval broke after near complete retraction of filter into sheath.Fda safety report id# (b)(4).

• Brand Name: COOK IVC FILTER RETRIEVAL SET TULIP
• Type of Device: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 14311785
• MDR Text Key: 291280921
• Report Number: MW5109561
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic