MAUDE Adverse Event Report: COOK MEDICAL / COOK, INC. STEADYSHEATH 13 FR EVOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number LR-TSS-13.0 / G25084

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

The outer sheath of the extraction set dislodged its radiopaque marker during a procedure.It not able to safely removed from the patient so was left in the patient's left upper chest.Fda safety report id# (b)(4).

• Brand Name: STEADYSHEATH 13 FR EVOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK MEDICAL / COOK, INC.; bloomington IN 47402 4195
• MDR Report Key: 13416713
• MDR Text Key: 284875595
• Report Number: MW5107089
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LR-TSS-13.0 / G25084
• Device Lot Number: N167924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White