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

Model Number	123F6P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per report received from austria, while trying to inflate the balloon with air and inject contrast media for a second time during a crt (cardiac resynchronization therapy) pacemaker procedure, the balloon of this swan-ganz catheter burst and a small piece of the balloon was missing; therefore, it did not inflate anymore.The catheter was withdrawn; the remaining balloon was confirmed to be attached to the catheter body.Then, the insertion catheter was flushed, and the balloon missing piece was searched in the working area without success.The device had been tested prior to use correctly.There was no allegation of patient injury.Patient demographics have been requested.The device was available for evaluation.
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.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.
Event or Problem Description
As reported, while trying to inflate for a second time the balloon with air and inject contrast media to check catheter position during a crt (cardiac resynchronization therapy) pacemaker procedure, the balloon of this swan-ganz catheter burst and a small piece of the balloon was missing; therefore it did not inflate anymore.The catheter was withdrawn; the remaining balloon was confirmed to be attached to the catheter body.Then, the guiding catheter was flushed, and the balloon missing piece was searched in the sterile area of the operating room and inside the patients body via fluoroscopy without success.The device had been tested prior to use correctly.No further intervention was performed.There was no allegation of patient injury.The patient is in good health.
Additional Manufacturer Narrative
As per information received, added information to section a2, a3 and updated b5 (the guiding catheter was flushed, and the balloon missing piece was searched in the sterile area of the operating room and inside the patients body via fluoroscopy without success.No further intervention was performed.The patient is in good health.
Additional Manufacturer Narrative
The device was received for evaluation.As received, balloon was found ruptured and the balloon latex edges did not appear to match up.Through lumen was patent without any leakage or occlusion.No other visible damage or inconsistency was observed from the catheter body or syringe.Evaluation results revealed that the reported event was confirmed.Further investigation was completed by the engineers in the manufacturing site, based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.All events will continue to be reviewed and monitored.

• Brand Name: SWAN-GANZ 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 20359087
• Report Number: 2015691-2024-07544
• Device Sequence Number: 15456822
• Product Code: DYG
• UDI-Device Identifier: 00690103000375
• UDI-Public: (01)00690103000375(17)241219(11)221220(10)64747054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233824
• 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): 12/11/2024

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: 12/19/2024
• Device Model Number: 123F6P
• Device Lot Number: 64747054
• Was Device Available for Evaluation?: No
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/15/2024; 12/05/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/11/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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 Age: 87 YR
• Patient Sex: Male