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

Model Number PX260

Device Problems Contamination /Decontamination Problem (2895); 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 04/20/2020

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 that before use in patient, while setting up this disposable pressure transducer (dpt), a foreign object was found inside the fluid path of the product.There was no allegation of patient injury reported.The device was available for evaluation.Patient demographics are not available.

Manufacturer Narrative

Th reported event of foreign object inside the fluid path of the product was confirmed.An unknown dark particulate, about 1mm in length, was found attached to the inner wall of pressure tubing at 15 cm from male connector. the noted particulate was not able to be flushed out during 5 minutes of continuous flushing.No other particulates found on filter paper. the material was sent for further analysis.A device history record review was completed and documented that device met all specifications upon distribution.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.  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

Additional investigation concluded that the unknown dark material at the male connector was consistent with material like pvc.The pressure tubing was also analyzed to show a spectrum consistent with pvc.The two different spectra were compared and showed 0.949 correlation, indicating that they are the same material.  being this product is manufactured by our supplier, a supplier notification was made for personnel about the condition.However, the condition will continue being monitored through the complaint system.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: TRUWAVE
• 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: 10045251
• MDR Text Key: 194828540
• Report Number: 2015691-2020-11828
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K183413
• 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
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62763890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1