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

Model Number PXVFP11470

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of disconnected pressure tubing was confirmed.As received, pressure tubing of planecta on distal side was detached from its housing.Bond indication was observed on bond area of the detached tubing.The findings were aligned to the customer photo.The other reported event of missing components was also confirmed.Distal end of pressure line, where the 30cm pressure tubing and planecta are supposed to be located, was missing.Location of 104cm pressure tubing was also found to be different.The 104cm pressure tubing was supposed to be between planectas, but the 104cm tubing was attached between 8cm pressure tubing and stand alone three way stopcock as received.Further evaluation regarding related quality issues is under investigation.The lot number was not provided thus a device history record was not reviewed.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 Description

It was reported that a waveform suddenly disappeared and a 3cm pressure tubing was found to be disconnected from the sampling site of a pressure monitoring device during use.The device was initially opened and used in the catheter room on (b)(6) without any reassembling and no extension tube was attached.The reported event occurred in the patients room on (b)(6).The customer commented that the kit was different from the other kits from the same model number as components ahead from the second planecta towards the distal end were missing.It is unknown if blood leakage was observed.The sales rep commented that the kit could be re assembled in the catheter room by the customer, though the customer alleged the kit was used immediately from the pouch.There were no patient complications reported.Patient initials are f.H, sex is male, height is 173cm, weight is 52.3kg, and age is 71 years.Patient has a medical history of acute myocardial infarction, acute cardiac failure, and dyslipidemia.The patient complained of chest pain and dyspneic and was carried to the catheter room in order to perform a cardiac catheterization.The event occurred after the procedure and when patient returned to the patient room.The customer commented that it was unknown what caused the pressure tubing detachment.Per additional information from sales rep, no troubleshooting or additional treatment was performed when the event occurred since it was found when the arterial line monitoring was finished and planned removal time of the pressure tubing.

Manufacturer Narrative

Additional visual evaluation was performed.Per drawing, male connector of 104cm pressure tubing was supposed to be bonded with female connector of planecta using adhesive loctite.Both male connector of 104cm pressure tubing and female connector of returned planecta were checked, but no clear bond indication was observed.Further evaluation regarding related quality issues is under investigation.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

The subject device component was sent to the third party manufacturer for evaluation.It was confirmed that tube was detached from planecta.Bond indication was observed on bond area, and it was determined that the tube was inserted properly.Manufacturing process was investigated, but no abnormality was observed.It was suspected that bent force and or tensile force were continuously applied to the tubing, and then bond joint come off and tubing was detached.However, root causes related to manufacturing process could not be determined during this investigation.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: PRESSURE MONITORING KIT
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16034520
• MDR Text Key: 306247678
• Report Number: 2015691-2022-10251
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2023

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 Model Number: PXVFP11470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 02/06/2023
• Supplement Dates FDA Received: 01/12/2023; 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 52 KG