MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CONTROLCATH TRUE SIZE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	C144F7
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during device prep, the balloon of a swan ganz catheter could not deflate.There were no patient injuries reported.Further information is not available.
Additional Manufacturer Narrative
Additional product codes are: dyg, dqe, kra.Multiple attempts were made for additional information and to secure the return of the device.However, the customer has not responded nor sent the device back 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.However, an investigation will be initiated to assess for any manufacturing related processes which could be correlated to the lot number.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 a part of the monthly review.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The complaint affected product was not returned for evaluation; therefore, a product non-conformance or device failure could not be confirmed.A device history record review was completed and documented that the device met all specifications upon distribution.Based on the available information, there is no evidence that supports or confirms the failure mode being evaluated to be associated to a manufacturing/design defect.As part of the manufacturing process, 100% of the manufactured units go through a balloon inflation process inspection.

• Brand Name: SWAN-GANZ CONTROLCATH TRUE SIZE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21865822
• Report Number: 2015691-2025-03017
• Device Sequence Number: 4684337
• Product Code: DQO
• UDI-Device Identifier: 00690103005134
• UDI-Public: (01)00690103005134(17)260327(11)240327(10)65691678
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160084
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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
• Device Expiration Date: 03/27/2026
• Device Model Number: C144F7
• Device Lot Number: 65691678
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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