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

Model Number T001759A

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

Patient Problem Burn(s) (1757)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

This non-conformance involves a dpt that burnt the patient while being used during magnetic resonance imaging (mri).This device is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.The ifu states that this device and the associated cable are not intended for use in the bore of the mr system and should not be in contact with the patient.This device and the associated cable may be in the mr system room but not in operation or connected to a pressure monitoring system during an mr examination.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 during a magnetic resonance imaging (mri) procedure, the disposable pressure transducer (dpt) with vamp, resulted in an approximate 1 cm squared thickness burn on the left upper quadrant an unsedated patient's arm.It was determined that the white flex cable between the dpt and the vamp was what burnt the patient.The device was available for evaluation.

Manufacturer Narrative

The patient injury caused by the disposable pressure transducer could not be confirmed.Two stains were detected from the returned sample.A black dot and a white stain were found on blue label dpt cable, both approximately 7" from dpt housing.A light brown stain and another white stain were also found on red label dpt cable, approximately 0.2" and 1" respectively from dpt housing.Both marks were consistent of alkyd resin.6m analysis concluded that these stains are part of the manufacturing process.Multiple attempts were made to schedule a re-education session for the physician however no response received.A customer letter, detailing the evaluation and pertaining ifu sections was sent to the customer.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

One double dpt - vamp plus kit with unsealed tyvek pouch from reported model and lot number was received for evaluation.The allegation of this disposable pressure transducer burning the patient was not able to be confirmed.Two customer photos were reviewed.The photos showed injury on the person's arm.However, no visible indication of damage or melting material was noticed from both dpt housings and cables.Visual inspection of the cables found an unknown black stain on the surface on both of the dpt cables.A black dot and a white stain were found on blue label dpt cable, both approximately 7" from dpt housing.A light brown stain and another white stain were also found on red label dpt cable, approximately 0.2" and 1" respectively from dpt housing.Per the ifu "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".No error message was observed on pressure monitor.Both dpts zeroed and sensed pressure accurately on pressure monitor.Electrical testing showed that both input impedances and output impedances of both red and blue dpt sensors respectively were within specifications.Zero-offset of blue sensor also met specification.No leakage or occlusion was detected from the kit during pressure test.Attempts have been made to contact the facility to follow up on the status of the patient but no further information is available.The facility will be re-educated on the instructions for use of disposable pressure transducers and mri incopatability.A device history record review was completed and documented that device met all specifications upon distribution.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 ; DR
• MDR Report Key: 11031737
• MDR Text Key: 222323941
• Report Number: 2015691-2020-15062
• 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: 11/30/2020

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 Expiration Date: 08/03/2022
• Device Model Number: T001759A
• Device Lot Number: 63299417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2021
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/11/2021; 02/05/2021
• Supplement Dates FDA Received: 02/04/2021; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68