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 Material Rupture (1546)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported a balloon of a cco swan seemed to have partially missing latex.Event was noticed after the swan was removed from the patient.Doctor experienced resistance after the catheter was successfully inserted into a mac 9 fr cvc diaphragm and past midcoil position.Initially the balloon could not passively deflate until the syringe was detached from the port.The balloon actively deflated 2mls and the partially missing latex was noticed after it was removed from the mac catheter.Doctor commented no force was used during the duration of use and removal.A new cco was uneventfully used thru the existing catheter.A cardiac surgeon examined the right atrium and the main, left, and right pulmonary arteries and saw no missing latex balloon fragments.The patient then underwent ct of the chest with iv contrast per pe protocol and no evidence of foreign body was seen.The malfunctioning cco swan was sent to risk management and the mac introducer will also be sent to risk management once removed from patient.

Manufacturer Narrative

Multiple attempts were made to secure return of the device however no response nor device was received for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.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

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.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: 16714016
• MDR Text Key: 313636483
• Report Number: 2015691-2023-12239
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)250116(11)230117(10)64840631
• 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: 05/22/2023

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: 64840631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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