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

Model Number 41229-02

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

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

Event Date 12/29/2021

Event Type  malfunction  

Event Description

The event involving a td catheter, 7f, 4 lumen, 110 cm, heparin coated, lf with mdr report# mw5106528, where it was reported that "during a cardiac catheter lab procedure, the staff was removing a swan-ganz catheter from the patient and 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.The staff tried to reinflate the balloon to test the integrity of it.While trying to inflate the balloon, they realized the balloon was no longer intact.A 20 cc syringe was attached to the side arm of the sheath to pull negative pressure.The staff was unable to pull back any blood on the sheath.The cardiologist was informed, and the staff was 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.The staff were able to retrieve what appeared to be in the balloon¿.There was patient involvement but no report of human harm.

Manufacturer Narrative

The device is available for evaluation but it has not been returned.The investigation is pending.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.Additional information: d9 - device available for eval changed from yes to no.

• Brand Name: TD CATHETER, 7F, 4 LUMEN, 110 CM, HEPARIN COATED, LF
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13660241
• MDR Text Key: 296771533
• Report Number: 1713468-2022-00001
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00840619043650
• UDI-Public: (01)00840619043650(17)220601(10)5450669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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 Model Number: 41229-02
• Device Catalogue Number: 412290402
• Device Lot Number: 5450669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 20CC SYRINGE, MFR UNK