MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 cco could not be measured with a swan ganz catheter and heparinized saline and catecholamine leakage was observed from the optical module connector on the third day of use.No additional treatment due to medication leakage was required.The catheter was not replaced and used continuously.An error message indicating cco not being measured appeared.Both of cco measurement and medication leakage issues were noted on (b)(6) 2022 in the icu after the operation for sinus of valsalva aneurysm removal performed on (b)(6) 2022.The patient initials were a.Y., gender male and age 72.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 64014044.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.

Manufacturer Narrative

The reported event of leakage from the optical module connector was confirmed, but cco measurement issue was not confirmed during evaluation.An interlumen leakage was observed between pa distal lumen and oximetry module at the backform.As received, blood residue was observed on the optical module connector.Optical module connector was opened and found no visible inconsistencies.Distal thermal filament cover binding site was torn.The torn edges matched up.Other through lumens were patent without any leakage or occlusion.No fault messages showed up on the lab hemosphere monitor when the catheter was connected.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.Thermistor temperature reading accuracy is +/- 0.3 c per hemosphere manual.The catheter ran cco in 37.0 c water bath on hemosphere monitor for 5 mins.Without error.Thermistor and thermal filament circuit were continuous, there were no open or intermittent conditions.No visible inconsistence was observed on eeprom data.Resistance value of thermal filament circuit was measured as 40.20 ohms.Both thermistor and thermal filament connectors were opened and found no visible inconsistencies.The balloon inflated clear, concentric and remained inflated for more than 5 mins.No visible damage was observed from catheter body, balloon, and returned syringe.Further evaluation regarding related quality issues is under investigation.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 CCOMBO V
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15577702
• MDR Text Key: 301481158
• Report Number: 2015691-2022-08474
• 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,Followup
• Report Date: 11/18/2022

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 Expiration Date: 10/27/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64014044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 11/04/2022
• Supplement Dates FDA Received: 11/02/2022; 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male