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

Model Number T530219D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 03/27/2023

Event Type  Injury  

Event Description

As reported, during a magnetic resonance imaging (mri) procedure, the patient got burnt by this truwave transducer.Patient suffered skin burns where transducer was in contact.No further information available.The device was not available for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

No product was returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.As reported, while using this pressure monitoring set (dpt) during a magnetic resonance imaging (mri) procedure, the patient skin was burnt due to contact with the dpt wire.The dfu states "this device and the associated cable are not intended for use inside of the bore of the mr system and should not be in contact with the patient".This warning is contained within the dfu and on the packaging of the device.Based on that, the event is not related to a product malfunction but a foreseeable side effect.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.

• Brand Name: TRUWAVE DISPOSABLE PRESSURE TRANSDUCE
• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16782909
• MDR Text Key: 313707433
• Report Number: 2015691-2023-12451
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K222216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T530219D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other