MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCO V CCO CEDV THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER OPTIC

Model Number 177F75N

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The reported event of leakage issue was confirmed.3 indentations were observed on the catheter body at 53 cm, 69.5 cm and 72 cm proximal from the tip.A cut was found on the catheter body at 72 cm proximal from tip, on the indentation.The cut was approximately 1.0 mm in length.Leakage was observed from the cut when air was injected into infusion lumen.No leakage was observed from other through lumens.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.No visible damage was found from balloon and returned syringe.A photo provided by customer showed the location of leakage, it appeared to be same as the cut, 72 cm proximal from the tip.Further evaluation regarding related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

Event Description

It was reported that the catecholamine leakage was observed from the swan ganz cco catheter during use for monitoring hemodynamics in patient with the dilated cardiomyopathy.The leakage occurred outside the patient, but the exact location of leakage was unknown.No additional treatment was reported.Patient is a male, 177 cm, and 103 kg.There were no patient complications reported.

Manufacturer Narrative

Lot number was previously unknown, but later identified from the eeprom data with the returned product.Lot number is 64268940.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Brand Name: SWAN GANZ CCO V CCO CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16765929
• MDR Text Key: 313563036
• Report Number: 2015691-2023-12393
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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 Expiration Date: 03/06/2024
• Device Model Number: 177F75N
• Device Catalogue Number: 177F75N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/04/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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
• Patient Sex: Male
• Patient Weight: 103 KG