MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PHOENIX DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PXVPP41434

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that blood leakage was observed due to the breakage of the pressure tubing of a pxvpp41434 vamp during use.The breakage was identified at the either side of 3cm pressure tubing near the planecta, located proximal to the vamp plus.The amount of leakage was small as it was noticed by the hospital staff immediately after the issue was identified.No blood transfusion nor prolonged hospitalization were needed.No patient injury was reported.Our product evaluation lab received one model pxvpp41434 vamp plus with attached pressure tubing.The customer report of issue with tubing of planecta was confirmed.As received, pressure tubing of planecta on distal side of the kit was detached from its housing.No other visible inconsistency was observed from returned sample.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.

Manufacturer Narrative

Jms is the supplier of the planecta and a supplier evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.It was confirmed that the tube was detached from planecta, bond indication was observed on the detached tube, and it was considered that the tube had been inserted properly.The planecta manufacturing process was investigated and no abnormality was observed.It is suspected that bent force and/or tensile force were continuously applied to the tubing during use, and then bond joint came off and the tubing became detached.However, root cause could not be determined during this investigation.Based on the available information there is no evidence that supports or confirms the failure mode is associated to an edwards lifesciences manufacturing/design defect.The lot number was not provided thus a device history record was not reviewed.

• Brand Name: PHOENIX DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: 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: erika bonilla ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18992218
• MDR Text Key: 338892846
• Report Number: 2015691-2024-02369
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXVPP41434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1