MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO V; CATHETER, OXIMETER, FIBER-OPTIC

Model Number 777F8

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/11/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of the balloon of a swan-ganz cco catheter did not inflate was confirmed.Balloon did not inflate due to leakage from a tear around circumference along proximal side of the balloon bonding area.The balloon latex edges were not able to match up.No deterioration was found from the balloon latex.All through lumens were patent without any leakage or occlusion.No visible damage was observed from catheter body and returned syringe.Further evaluation regarding supplier 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.

Event Description

The balloon of a swan ganz cco catheter did not inflate during balloon testing before use.There was no patient involvement.

• Brand Name: SWAN GANZ CCOMBO V
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14435608
• MDR Text Key: 292033522
• Report Number: 2015691-2022-05757
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/18/2022

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 Expiration Date: 03/08/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63661461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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