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

Model Number	PXVP0566
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pxvp05066 tubing was not glued properly and coming apart.There was no allegation of patient injury.
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 when the investigation is completed.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
The device was not returned therefore no evaluation could be performed since no objective evidence such as product samples, imagery, or videos was provided for investigation.The lot number was not provided thus a device history record was not reviewed.As such, based on available information, a definite root cause is unable to be determined at this time.The reported malfunction could not be confirmed since no product samples nor images was provided, however, there are manufacturing controls to avoid potential causes related to the malfunction such as 100% visual inspection, manufacturing continuous monitor sampling, and qa sampling inspection.

• Brand Name: TRUWAVE, VAMP PLUS
• 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 LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19968737
• Report Number: 2015691-2024-06070
• Device Sequence Number: 8898000
• Product Code: DXO
• UDI-Device Identifier: 07460691955172
• UDI-Public: 07460691955172
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: PXVP0566
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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