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

Model Number 774F75

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Manufacturer Narrative

The reported event of balloon issue was confirmed.Balloon was found to be torn around circumference at both proximal and distal bonding sites.Torn balloon piece was not returned.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from the catheter body.Further evaluation regarding supplier related quality issues is under investigation.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 that the balloon of the cco catheter ruptured during balloon test prior to use for a cardiac surgery.Per the sales rep., the balloon was to be deflated with the syringe included in the package, but it ruptured.The physician commented that the excessive pressure was not applied.The catheter was exchanged with a new one, and the surgery was completed without any issues.There were no patient complications reported.Date of event is unknown.

Manufacturer Narrative

A device history record review was completed and documented that device met all specifications upon distribution.Engineering evaluation completed and concluded a product risk assessment was needed.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
• 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: 15135644
• MDR Text Key: 302723002
• Report Number: 2015691-2022-07096
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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: 10/12/2023
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 64014045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• 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