MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Pacing Problem (1439)

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

Event Type  malfunction  

Manufacturer Narrative

The reported event of pacing issue was confirmed.Continuity test found that a full open condition of the distal circuit in y adapter.The proximal circuit was found to be continuous.No open or short condition was observed in the lead wires between just distal side of y adapter and the electrodes.No visible damage or abnormality was observed from catheter body, balloon, windings, and returned syringe.The balloon inflated clear and concentric and remained inflated for 5min without leakage.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 a swan ganz catheter was unable to pace after insertion during use.The issue was resolved by replacing the catheter.Information such as the phase when the catheter got unable to pace, what kind of surgery and examination the catheter was used for or if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.Date of event is unknown.

Manufacturer Narrative

Additional information was obtained during product investigation.The reported event of pacing issue was confirmed.Continuity test found that a full open condition of the distal circuit in y adapter.The proximal circuit was found to be continuous.No open or short condition was observed in the lead wires between just distal side of y adapter and the electrodes.After opening y fitting, the distal lead wire was found to be caught in the housing of the y fitting.The distal lead wire was accidentally cut during opening the y fitting because it was caught in the housing.No visible damage or abnormality was observed from catheter body, balloon, windings, and returned syringe.The balloon inflated clear and concentric and remained inflated for 5min without leakage.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.

Manufacturer Narrative

Engineering evaluation was completed and concluded that 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 BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15099840
• MDR Text Key: 301942861
• Report Number: 2015691-2022-07009
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• 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,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/10/2023
• Device Model Number: PE074F5
• Device Lot Number: 64099181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2021
• 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