MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWANGANZ CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER OPTIC

Model Number 777F8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation 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 the catheter was sewn into the heart tissue of the patient, and blood leakage was observed from the optical module connector during use.The patient was an adult.At the time of the event the patient was not in stable condition.Follow up for additional information is ongoing.

Manufacturer Narrative

The reported event of leakage issue was confirmed.3 punctures were found on the catheter body.Puncture a was 1.0 mm, puncture b was less than 0.5 mm, and puncture c was 1.5 mm in length.The thermistor, thermal filament and optical module connector extension tube were cut in half just distal of the connector for leak testing.Leakage was observed from the puncture a and c when air was injected into the pa distal lumen, proximal injectate lumen and optical module lumen.No leakage was observed from other through lumens, thermistor lumen and thermal filament lumen.Puncture b did not appear to enter any lumens.As received, the blood stain was observed inside of strain relief of optical module connector.Optical module connector was opened and the blood was observed inside of the connector.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.Distal thermal filament cover bonding site was torn.The torn edges appeared to match up.No other visible damage or abnormality was found from balloon and returned syringe.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: SWANGANZ CCOMBO V CCO SVO2 CEDV VIP 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: 15997647
• MDR Text Key: 305633172
• Report Number: 2015691-2022-10076
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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