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

Model Number	096F6P
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional fda product codes include: dyg- catheter, flow directed.Dqe- catheter, oximeter, fiberoptic.Kra- catheter, continuous flush.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 when testing a swan before inserting into the patient the balloon would not deflate.The doctor and rep both attached/reattached the syringe to the balloon, tried to deflate it, but it stayed inflated.There was no patient injury.
Additional Manufacturer Narrative
One model 096f6 catheter with a 1 ml syringe was returned for evaluation.The reported issue of balloon would not deflate was unable to be confirmed.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 1 second without the syringe attached.Maximum deflation time for full capacity is 4 seconds.As stated in the ifu, passively deflate the balloon by removing the syringe and opening the gate valve.All through lumens were patent without any leakage or occlusion.No visible damage was observed on the catheter.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.The issue of balloon not able to deflate was unable to be confirmed through product evaluation since the affected unit was returned for evaluation and no defect was found.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.The ifu also contains the following precautions: it is recommended that the provided syringe be re-attached to the gate valve after balloon deflation to prevent inadvertent injection of liquids into the balloon lumen; if a right ventricular pressure tracing is still observed after advancing the catheter several centimeters beyond the point where the initial right ventricular pressure tracing was observed, the catheter may be looping in the right ventricle which can result in kinking or knotting of the catheter.Deflate the balloon and withdraw the catheter into the right atrium.Re-inflate the balloon and re-advance the catheter to a pulmonary artery wedge position, then deflate the balloon.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.

• Brand Name: SWAN-GANZ 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 IRVINE; 1 edwards way; irvina CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 20291947
• Report Number: 2015691-2024-07327
• Device Sequence Number: 8126934
• Product Code: DQO
• UDI-Device Identifier: 00690103000245
• UDI-Public: (01)00690103000245(17)260228(11)240229(10)65612307
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 02/28/2026
• Device Model Number: 096F6P
• Device Lot Number: 65612307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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