MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO; 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 01/21/2022

Event Type  malfunction  

Event Description

It was reported that the balloon of swan-ganz cco catheter did not inflate during balloon testing before use.There was no patient involvement.

Manufacturer Narrative

The reported event of did not inflate was confirmed.Balloon did not inflate due to a tear, approximately 0.01 inches in length near the central area of the balloon.The edges of latex did not appear to match at the torn location.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body.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.

• 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, puerto rico 00610 ; * 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco, puerto rico 00610 ; * 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 13860472
• MDR Text Key: 287673707
• Report Number: 2015691-2022-04558
• 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: 03/22/2022

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: 03/29/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63707542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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