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

Model Number	111F7P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The specific occurrence date could not be obtained.The event occurred on june 2024 but the day was unknown.One swan-ganz catheter was received by our product evaluation laboratory for a full examination.As received, the balloon was found to be ruptured next to distal end and the balloon edges appeared not to match at the ruptured region.On the other hand, through lumens were patent without any leakage or occlusion.No other visible damage was observed from catheter body.The reported event was confirmed.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, after inserting this swan-ganz catheter, while inflating, the doctor felt a drop of air and the balloon was torn.The catheter was removed from the patient's body.The balloon had been inflated with the dedicated syringe that comes in the kit and prior to insertion, the doctor had tested the balloon in a tub of water and the balloon was normal.There was no allegation of patient injury.The device was available for evaluation.As per evaluation results, the balloon was found to be ruptured next to distal end.The balloon edges appeared not to match up at the ruptured region.
Additional Manufacturer Narrative
Patient demographics unable to be obtained.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/ design defect.The controls to defect the failure mode being evaluated are established in the manufacturing process.As part of the manufacturing process, the manufactured units go through a balloon inflation process.

• 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 ; 9492503939
• MDR Report Key: 20045655
• Report Number: 2015691-2024-06366
• Device Sequence Number: 12746105
• Product Code: DYG
• UDI-Device Identifier: 00690103000276
• UDI-Public: (01)00690103000276(17)250404(11)230405(10)64935037
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 04/04/2025
• Device Model Number: 111F7P
• Device Lot Number: 64935037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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