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

Model Number 777F8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/19/2023

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.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, there was patient injury during the replacement of a malfunctioned swan ganz catheter.When the catheter was placed in the patient and balloon was inflated, pressures increased to 90.Staff exchanged the oximetry cable and cco cable, but issue continued.Catheter was removed which caused bleeding at the back form coris diaphragm.A new swan ganz catheter was placed.Patient had a diagnosis of acute nstemi, medical hx with comorbidities of hypertension, hld, hypothyroidism, cad, acute kidney injury, and obstructive sleep apnea.Per follow up with customer, there was bleed back from cortis valve while trying to float the catheter through the introducer into the artery.Both the cvp and pa pressure increased to 90 when the balloon was up.But returned to normal when the balloon was down.The expected values were in the teens.Issue was resolved by replacing the devices with a new introducer kit and swan ganz.The second attempt had no placement issues and the cvp and pa readings were normal.Initially, it was reported, that there was patient injury.Customer confirmed, there were no patient injuries and no additional treatments needed.

Manufacturer Narrative

The reported event of pressure issue was unable to be confirmed.All through lumens were patent without any leakage or occlusion.All through lumens passed pressure test with lab dpt.Balloon inflated clear and concentric, and remained inflated for 5 minutes.One customer image was reviewed.Customer image showed the packaging label of the returned sample.Further evaluation regarding related quality issues is under investigation.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 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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16955444
• MDR Text Key: 315556042
• Report Number: 2015691-2023-13078
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)250220(11)230221(10)64912992
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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 Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64912992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 89 KG