MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR VOLUME VIEW SENSOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	VLV8R520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during use in a patient in the cardiac icu (intensive care unit), when handling the manifold of this volumeview sensor, it broke into two pieces (complaint (b)(4)).The device was replaced by a new one and, after two days of use, the manifold also broke into two pieces (complaint (b)(4)).A third device was used.The blood loss was minimal.There was no allegation of patient injury.The devices were not available for evaluation since they were discarded; however, an image of the device involved in the complaint (b)(4) was available.
Additional Manufacturer Narrative
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.No product is available to be returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.
Additional Manufacturer Narrative
Updated section a2 (age at time of the event), a3a(sex), a4(weight), h6(component code), h6(type of investigation), h6(investigation findings) and h6 (investigations conclusions).The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on available information, and since no product sample nor objective evidence was provided for investigation, a definite root cause is unable to be determined.There are manufacturing controls to avoid potential causes related to the reported malfunction.Corrected data: corrected section d3(manufacturer), g1(establishment name).

• Brand Name: VOLUME VIEW SENSOR
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; carr. sanchez km 18.5; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; carr. sanchez km 18.5; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 21111872
• Report Number: 2015691-2025-00170
• Device Sequence Number: 8682354
• Product Code: DRS
• UDI-Device Identifier: 00690103187014
• UDI-Public: (01)00690103187014(17)250720(11)230829(10)65237782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2025
• Device Model Number: VLV8R520
• Device Lot Number: 65237782
• Was Device Available for Evaluation?: No
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG