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

Model Number	PE074F5
Medical Device Problem Codes	Pacing Problem (1439); No Pacing (3268)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catheter was discarded at the facility and not available for return and evaluation.The lot number is unknown.The device history record review cannot be completed.An engineering investigation has been initiated.Once the results are available a supplemental report will be submitted.
Event or Problem Description
It was reported that the swan ganz bipolar pacing catheter did not pace, during patient use.The catheter was replaced and then the issue was resolved.There are limited details available.Details regarding lot number, malfunction details, procedure type, patient demographics, are unknown.There was no patient harm or injury.The device was discarded by the hospital.There is no product return.
Additional Manufacturer Narrative
The device was discarded and not available for return.Therefore, the device failure could not be confirmed.As part of the manufacturing process 100 percent of the units go through an electrical inspection process.Without its return it is not possible to determine if some damage or defect existed on the device that could have contributed to the event.Since the product was not evaluated there is not sufficient evidence to determine if this complaint was related to manufacturing, design, or labeling.It is not known if any procedural factors may have contributed to the event.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 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.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards lifesciences; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 20398255
• Report Number: 2015691-2024-07643
• Device Sequence Number: 15072831
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: PE074F5
• Was Device Available for Evaluation?: No
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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