MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V

Model Number 777F8

Device Problem Material Fragmentation (1261)

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

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model 777f8 catheter with a monoject limited volume syringe and a non-edwards contamination shield.The catheter passed in-vitro calibration with a lab cal-cup.The catheter also passed an attenuation test.The balloon latex appeared deteriorated with multiple cracks evident.Leakage was observed through cracks on the deteriorated latex.The balloon edges did not appear to match up at the cracks.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body or the returned syringe.A device history record review has been initiated and a supplemental report will be filed upon completion.The customer report of an svo2 issue was unable to be confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that a model 777f8 swan-ganz catheter, lot 64446892, intermittently displayed a greyed out svo2 reading.There was no alarm associated with the issue.There was no patient injury.The date of the event was on or around (b)(6) 2023.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A capa to address the catheter general confirmed error message failure mode is currently in its implementation phase.For condition balloon - latex deterioration, it was able to be confirmed that during the decontamination process the balloon did not appear deteriorated and inflated.The catheter was immersed in metricide, rinsed with water, allowed to air dry and then bagged and passed to the product evaluation laboratory.When the catheter arrived at product evaluation the balloon appeared deteriorated and was unable to inflate.Latex deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone.Appears on the balloon surface as a maze of fine cracks or crazing.The condition may occur in a small area or cover the entire balloon.The manufacturing process was verified, and no objective evidence was found to indicate that this condition was generated in the process.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: SWAN-GANZ CCOMBO V
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 16570533
• MDR Text Key: 311578672
• Report Number: 2015691-2023-11581
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64446892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/19/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2022
• 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