MAUDE Adverse Event Report: ICU MEDICAL, INC. TD CATHETER 7F 4LUMEN 110CM HEPARIN COATED, LF; CATHETER, OXIMETER, FIBER-OPTIC

Lot Number 5450669

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2021

Event Type  Injury  

Event Description

During a cardiac cath lab procedure, staff was removing a swan-ganz catheter from the patient.They proceeded to deflate the balloon before pulling the catheter from the sheath.After deflating the balloon, they began to pull back the catheter.While pulling the last portion of the catheter out, there was mild resistance encountered, but not enough to make them think that the balloon was caught.After fully removing the catheter from the sheath, they noticed that the tip of the balloon didn't look normal.Staff tried to reinflate the balloon to test the integrity of it.While trying to inflate the balloon, they realized that the balloon was no longer intact.A 20 cc syringe was attached to the side arm of the sheath to pull negative pressure.Staff was unable to pull back any blood on the sheath.The cardiologist was informed.Staff were instructed to continue pulling negative on the syringe while the cardiologist discontinued the 7fr.Sheath.After removing the 7fr.Sheath from the femoral vein, the sheath was flushed to see if the balloon plastic was in the sheath.Staff were able to retrieve what appeared to be the balloon.Fda safety report id# (b)(4).

• Brand Name: TD CATHETER 7F 4LUMEN 110CM HEPARIN COATED, LF
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; san clemente CA 92673
• MDR Report Key: 13205848
• MDR Text Key: 283610912
• Report Number: MW5106528
• Device Sequence Number: 1
• Product Code: DQE
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Lot Number: 5450669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White