MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	PXVP2284AT3
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.
Event or Problem Description
It was reported that a truwave vamp had silicone overspray.Issue was noticed prior to use.No patient injuries reported.
Additional Manufacturer Narrative
No engineering evaluation could be performed since no objective evidence such as product samples, imagery, or videos was provided for investigation.Reviews of the device history record, lot history and manufacturing mitigations revealed no indication that a manufacturing nonconformance contributed to the reported complaint.As such, based on available information, a definite root cause is unable to be determined at this time.Corrections to the h6 codes investigation findings and investigation conclusions were made.
Additional Manufacturer Narrative
The device was not returned for evaluation.It was previously reported that the device was available for return, but it was discarded.Without the 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.No corrective actions will be taken at this time.A supplemental report for the device history record will be forthcoming when the investigation is completed.Corrections to the h6 codes type of investigations were made.

• Brand Name: PRESSURE MONITORING KIT
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18574638
• Report Number: 2015691-2024-00562
• Device Sequence Number: 8915155
• Product Code: DXO
• UDI-Device Identifier: 07460691950436
• UDI-Public: (01)07460691950436(17)250907(11)230908(10)65304145
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K925638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

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
• Device Expiration Date: 09/07/2025
• Device Model Number: PXVP2284AT3
• Device Lot Number: 65304145
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 02/12/2024; 03/14/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/29/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• 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