MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ; SWAN GANZ BIPOLAR PACING CATHETER

Model Number	D97130F5
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the swan ganz bipolar pacing catheter did not pace, during use.Only limited details were provided.The exact date of the occurrence is unknown.There was no patient injury.Patient demographics were requested and not provided.There was no report of inappropriate patient treatment.
Additional Manufacturer Narrative
The device was returned for evaluation.The reported issue that the device would not pace was confirmed.Continuity testing confirmed a full open condition in both distal and proximal circuits.The catheter body was cut down to expose the pacing lead wires.The distal wire was damaged at the solder.The proximal wire was broken near the distal tip.The insulation was not present on the lead wire at the damaged location.The device balloon inflated clear and concentric with 1.3 cc of air.It remained inflated for five minutes without leakage.There was no visible damage observed from the catheter, balloon or windings.An engineering evaluation was initiated.Based on the product evaluation results there is no evidence that supports or confirms the issue is associated with a manufacturing or design defect.As part of the manufacturing process 100 percent of the units go through an electrical inspection process.The instruction for use provides direction for preparation techniques and insertion procedure steps as a guideline and an aid for the physician.A precaution is given to avoid forceful wiping or stretching of the catheter during testing and cleaning so as not to break the electrode wire circuitry.Proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires.Care should be taken when handling the catheter.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.The device history record review could not be completed as the serial lot number is unknown.

• Brand Name: SWAN GANZ
• Common Device Name: SWAN GANZ BIPOLAR PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 20472871
• Report Number: 2015691-2024-07903
• Device Sequence Number: 15354344
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K822723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

1 Device was Involved in the Event

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 Model Number: D97130F5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2024
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/19/2024
• 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