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

Model Number TC1108S04

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

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.

Event Description

It was reported that unknown material was found inside of the three way stopcock of a disposable pressure transducer system.This was noted before use on a patient.Patient demographic information requested but unavailable.There were no patient complication reported.The device is available for examination.

Manufacturer Narrative

Chemistry results of a particulate that was found inside a three-way stopcock in a disposable pressure transducer indicated that the ir spectrum of the unknown clear material showed similar absorption characteristics when comparing to rubber-silicone elastomer like material.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint, including if the rubber-silicone material from the chemistry findings is associated with any component of the manufacturing process.A supplemental report will be sent with the investigation results.

Manufacturer Narrative

Per the engineering assessment, after reviewing the product evaluation, it was confirmed that the particle was not within the fluid path and it is specified that it did not move despite changing the stopcock handle in different positions and performing a continuous flush for 5 minutes.The supplier personnel was notified about the condition.

Manufacturer Narrative

A visual examination confirmed that an unknown clear material was observed inside of the vent port of the zero-stopcock.The zero-stopcock handle was turned several times, but the clear material did not get into the fluid path of the kit.Continuous flushing for 5 minutes also did not flush out the material.The material was cube-shape like and it was approximately 1 x 1 x 1mm in size.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A supplemental submission will be submitted after chemistry analysis.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.Particulates that are in the fluid path could enter the bloodstream, potentially embolizing and resulting in patient injury or infection.In this case there was no patient involvement.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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 ; DR
• MDR Report Key: 8187078
• MDR Text Key: 131340671
• Report Number: 2015691-2018-05491
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/06/2018

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 Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Model Number: TC1108S04
• Device Lot Number: KL0168MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/10/2019; 01/28/2018; 03/06/2019; 07/23/2020
• Supplement Dates FDA Received: 01/18/2019; 02/21/2019; 03/08/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1