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

Model Number PXVFP11135

Device Problem Contamination (1120)

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

Event Date 07/31/2023

Event Type  malfunction  

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 Description

It was reported that a black foreign material was found inside the reservoir before use.The package had been opened.There were no patient complications reported.

Manufacturer Narrative

Further evaluation regarding supplier related quality issues stated that the ir spectrum of the white and brown particulate was consistent with that of synthetic latex.An additional device history record review was completed for the edwards component lot 64702647.It was documented that the device met all specifications upon distribution.Lot was manufactured on 02nov22 and expires on 17oct24.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 reported event of foreign material was found inside the reservoir was confirmed.One white and brown particulate was observed inside vamp flex reservoir during visual examination.The particulate was approximately 3 mm x 1 mm in size.Plunger of vamp flex was pushed to closed position at rate of 1ml per 1 second, but the particulate stayed at the same location on piston inside vamp flex reservoir.It was recommended by ifu to move the plunger at rate of 1ml per 1 second.The whole line was flushed continuously for 5 minutes, but the particulate stayed inside vamp flex after 5 minutes of continuous flushing.No other visible defect or damage was observed on returned kit.Further evaluation regarding related quality issues is under investigation.The device history record review for lot yh0238mt was completed by a third party to check the third party assembly process.It was documented that the device met all specifications upon distribution.An additional device history record will be forthcoming review for the edwards component lot 64702647.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

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.During the product investigation, it was identified that the particle was found inside the syringe and after the line was flushed continuously for 5 minutes, the particulate stayed, which means that it could be an embedded particle.The involved component is manufactured by a third party supplier.A corresponding supplier notification was sent due to mail by the supplier quality team.Corrections to the h6 codes investigation findings and investigation conclusions were made.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: 17574887
• MDR Text Key: 321455201
• Report Number: 2015691-2023-15328
• 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,Followup
• Report Date: 10/30/2023

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: PXVFP11135
• Device Lot Number: YH0238MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 08/22/2023; 09/08/2023; 10/24/2023
• Supplement Dates FDA Received: 09/06/2023; 09/26/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2022
• 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