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

Model Number	D205F7
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.
Event or Problem Description
It was reported that it was unable to pace during use.The following information was unavailable: background of malfunction occurrence, the phase when the catheter got unable to pace, what kind of surgery/examination the catheter was used for, whether the patient had cardiac conduction defect or whether the catheter was replaced.Patient demographic information was requested but unavailable.There were no patient complications reported.
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): d1 brand name: swan-ganz pacing td catheter d2a common device name: electrode, pacemaker, temporary d2b device product code: ldf.
Additional Manufacturer Narrative
Our product evaluation lab received one model d205f7 pacing catheter.The customer report of pacing issue was confirmed.No other visible damage or inconsistency was 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 (#1) and in the atrial distal circuit (#3) respectively.The rest of the circuits (#2, 4, 5) were continuous without short conditions.Further examination confirmed that the ventricular distal leadwire was broken/detached around electrode #1 and that the atrial distal leadwire was broken/detached around electrode #3.It was also confirmed that the ventricular distal circuit (#1) was continuous from the broken lead wire to ventricular distal pin and that the atrial distal circuit (#3) was continuous from the broken lead wire to atrial distal pin.An engineering evaluation was preformed to assess for any manufacturing related processes which could be correlated to the complaint, a manufacturing root cause could not be confirmed.The ifu contains a precaution: avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode or thermistor wire circuitry.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 PACING TD CATHETER
• Common Device Name: 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 ; 9492507258
• MDR Report Key: 18258966
• Report Number: 2015691-2023-17901
• Device Sequence Number: 19854506
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024
• 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
• Device Model Number: D205F7
• Device Lot Number: 65155988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/31/2024; 07/24/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/31/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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