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

Model Number 774F75

Device Problem Material Rupture (1546)

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

Event Date 03/11/2023

Event Type  malfunction  

Event Description

It was reported that the balloon of the swan ganz cco catheter ruptured during use.During catheter insertion, a resistance was felt when the user deflated the balloon once and reinflated.The echo showed microbubbles in the right heart at the time of reinflation of the balloon.When the catheter was removed and checked, the balloon rupture was confirmed.The details of introducer used with the catheter was unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported balloon rupture event was confirmed.Balloon was found to be torn around the circumference in the center of the balloon.Latex between the proximal and distal bonds was not returned.Resistance was felt when air was injected into balloon inflation lumen, and the clotted blood was observed from balloon inflation port.After clotted blood was removed in hot water, air was injected into inflation lumen with no resistance.All through lumens were patent without any leakage or occlusion.Residual latexes were visible at both proximal and distal balloon bonds.No visible damage or inconsistency was observed from the catheter body or returned syringe.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.

Manufacturer Narrative

Engineering evaluation was completed.Updates to the h6 codes are as follows investigation findings was changed to no findings available and investigation conclusions was changed to cause not established.Lot number was previously unknown, but later identified from the eeprom data with the returned product.Lot number is 64189747.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 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: 16784720
• MDR Text Key: 313947320
• Report Number: 2015691-2023-12457
• 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: 06/27/2023

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?: Yes
• Device Expiration Date: 01/31/2024
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2022
• 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 Outcome(s): Other