MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ BIPOLAR PACING CATHETER AND KIT FOR SUPERIOR VENA CAVA INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PEK074F5

Device Problem Pacing Problem (1439)

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

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event of pacing issue was confirmed.Continuity testing found that a short condition occurred in the catheter body.Cut down was performed and revealed that the insulation of proximal lead wire was missing from under the proximal electrode to 3.0 cm from catheter tip.Insulation of distal lead wire was partially missing from under the proximal electrode to 3.9 cm from catheter tip.This condition allowed the leadwires to make contact and caused the short condition.After separating both wires, no short condition was observed, and continuous condition was confirmed between distal electrode and distal connector pin and between proximal electrode and proximal connector pin.The balloon inflated clear and concentric and remained inflated for 5min.Without leakage.No visible damage was observed from catheter body, balloon, windings, and returned syringe.Further evaluation regarding 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 a swan ganz was unable to pace during use.The issue was resolved by replacing the catheter.Information such as the background of malfunction occurrence, the phase when the catheter got unable to pace, what kind of surgery or 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.

Manufacturer Narrative

Engineering evaluation was completed.A capa was initiated and a product risk assessment was met earlier.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 BIPOLAR PACING CATHETER AND KIT FOR SUPERIOR VENA CAVA INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16391791
• MDR Text Key: 310147168
• Report Number: 2015691-2023-10886
• 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
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PEK074F5
• Device Lot Number: 64382161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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