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

Model Number	D97130F5
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2024
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 when the results become available.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that during use, d97130f5 swan-ganz bipolar pacing catheter from lot 65369611, did not capture.The wire was introduced into the rv under fluoroscopic guidance.Good capture and sensing was confirmed, but loss of capture and sensing was noted several minutes later, despite unchanged lead position.The swan-ganz pacing catheter was removed and replaced with another one.Good capture and sensing was confirmed.Loss of capture and sensing was noted again several minutes later, despite unchanged lead position.The external hardware components (connecting cable and temporary pm box) were replaced but again showed exit block and no sensing, suggesting failure of the swan-ganz catheter lead again.The catheter was removed and the physician elected to place permanent pacemaker.
Additional Manufacturer Narrative
No product was returned for evaluation.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A device history record review was completed and documented that device met all specifications upon distribution.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Common Device Name: 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: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 19805566
• Report Number: 2015691-2024-05570
• Device Sequence Number: 8379504
• Product Code: DYG
• UDI-Device Identifier: 00690103150438
• UDI-Public: (01)00690103150438(17)251018(11)231019(10)65369611
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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 Expiration Date: 10/18/2025
• Device Model Number: D97130F5
• Device Lot Number: 65369611
• Was Device Available for Evaluation?: Yes
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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