MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING TD CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	D205F7
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.
Event or Problem Description
It was reported that during use of this pacing catheter, it was unable to pace.This was after the catheter insertion during a minimally invasive cardiac surgery (mics).The issue was resolved by replacing the catheter.It is unknown whether the patient had cardiac conduction defect.Patient demographic information was requested but unavailable.There was no malfunction regarding atrial pacing reported.There were no patient complications reported.
Additional Manufacturer Narrative
One d205f7 catheter with an attached monoject volume limited 1.3 cc syringe at gate valve was returned for examination.The reported event of a pacing issue was confirmed.There was no visible damage or inconsistency observed from catheter body, syringe, connectors and balloon.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Continuity testing found that there was an open condition in the ventricular distal circuit and in the atrial distal circuit respectively.The rest of the circuits were continuous without short conditions.Further examination found that the ventricular distal leadwire was broken at 6.5 mm proximal from the electrode.It was also found that the atrial distal leadwire was broken and detached around an electrode.It was also confirmed that the ventricular distal circuit was continuous from the broken lead wire to ventricular distal pin and that the atrial distal circuit was continuous from the broken lead wire to atrial distal pin.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.The root cause could not be established.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.Corrected data: updates to the h6 codes are as follows: type of investigation was changed to testing of actual/suspected device, historical data analysis, communication/interviews.Investigation findings was changed to electrical problem identified.Investigation conclusions was changed to cause not established.
Additional Manufacturer Narrative
Udi related data quality updates only the udi number is: (b)(4).The following is corrected data, as the original identification information sent did not match the data submitted to the global unique device identification database (gudid): d2a common device name: electrode, pacemaker, temporary d2b device product code: ldf.

• Brand Name: SWAN-GANZ PACING TD CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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 ; 9492017706
• MDR Report Key: 18293243
• Report Number: 2015691-2023-18229
• Device Sequence Number: 6168378
• Product Code: LDF
• UDI-Device Identifier: 00690103197334
• UDI-Public: (01)00690103197334(17)250802(11)230803(10)65155988
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K791183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2025
• Device Model Number: D205F7
• Device Lot Number: 65155988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 02/01/2024; 07/29/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/12/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown