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

Model Number TC0160S02

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not 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 before use of this disposable pressure transducer, that white spots were observed inside of the pressure tubing in an opened pouch before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One pressure tubing was returned for examination.The reported event of contamination issue was confirmed.One clear material was observed inside of the tubing on the inner tubing wall near the female connector.The clear material was approximately 1mm x 1mm in size.The material stayed at the same location inside of the pressure tubing after 5 minutes of continuous flushing.The pressure tubing was cut, and a part of the material was found embedded within the inner tubing wall.A review of the manufacturing records indicated that the product met specifications upon release.Per chemistry study the ir spectrum of the unknown material showed similar absorption characteristics when comparing to polyethylene like material, which is the tubing material.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.In this case the particulates were found before the unit was connected to the patient.The noted particulate was not able to be flushed out during 5 minutes of continuous flushing.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

Reference capa-20-00141.

• Brand Name: 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 ; DR
• MDR Report Key: 8915523
• MDR Text Key: 192200753
• Report Number: 2015691-2019-03098
• 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
• Report Date: 07/30/2019

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: 12/31/2020
• Device Model Number: TC0160S02
• Device Lot Number: LC0252MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 08/25/2019; 07/23/2020
• Supplement Dates FDA Received: 09/18/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1