MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRUWAVE, VAMP PLUS; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXVFP11298
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and is being evaluated.When the product evaluation has been completed the findings will be submitted in a supplemental report.The lot serial number is unknown.When the lot serial number has been obtained, the device history record review will be completed and the results included in a supplemental report.
Event or Problem Description
It was reported that the red septum cover, the housing of the planecta, on a pressure monitoring set, was found to be detached.This was found during patient use.There is no further information available.The exact occurrence date is unknown.There is no patient injury reported.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to a change in reportability.Per the evaluation, the septum cover/housing was not detached as reported, therefore this event is no longer reportable.The product evaluation has been completed.It was found that the septum cover/housing was not detached as reported.The red cap was attached to its housing.Further investigation found that the planecta lock or male luer could not be attached due to interference from inside of the sample.The reported issue could not be confirmed.The lot/serial number was unable to be obtained, therefore, the device history record review was unable to be completed.Refer to kra as an additional product code.There was no evidence of a manufacturing nonconformance.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.

• Brand Name: TRUWAVE, VAMP PLUS
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; parque industrial de itabo; carr sanchez km 18.5, dominican republic
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 19822969
• Report Number: 2015691-2024-05632
• Device Sequence Number: 8891365
• Product Code: DXO
• UDI-Device Identifier: 07460691956247
• UDI-Public: (01)07460691956247
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Model Number: PXVFP11298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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