MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT; CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Pacing Problem (1439)

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

Event Date 09/21/2023

Event Type  malfunction  

Event Description

It was reported that during use of this pacing catheter, it was unable to pace after the catheter insertion.The issue was resolved by replacing the catheter.The following information was unavailable: what kind of surgery or examination the catheter was used for or whether the patient had cardiac conduction defect.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.

Manufacturer Narrative

One bipolar pacing catheter with an attached monoject volume limited 1.3 cc syringe was returned for examination.The reported event of a pacing issue was confirmed.The continuity test found that there was a full open condition of the proximal circuit in y adapter.The distal 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.A short condition was not detected in the circuit proximal of y adapter.There was 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 five minutes without leakage.A device history record review was completed and documented that device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the available information, it cannot be confirmed that the failure condition being evaluated is associated to design or the manufacturing process or that there was a product non-conformance that potentially contributed to the complaint.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 part of this monthly review.Correction: updates to the h6 codes are as follows: investigation findings was changed to open circuit.Investigation conclusions was changed to cause not established.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17927774
• MDR Text Key: 325580028
• Report Number: 2015691-2023-16764
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Lot Number: 64752349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2022
• 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