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

Model Number MP7212_

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

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

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.A statement in the ifu under the complications section states: air emboli - air can enter the patient through stopcocks that are inadvertently left open, from accidental disconnection of the pressure setup, or from flushing residual air bubbles into the patient.It is not known if some user or procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.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.

Event Description

It was reported that during use of a disposable pressure transducer, air inclusion was observed from the pressure tubing.During a cerebral angiography examination air was included in the pressure tubing and the air reached to the intracranial blood vessel through a catheter.Air inclusion in the catheter was observed during imaging, the customer stopped injection of a contrast medium through an injection system immediately and there were no patient complications reported.The air was removed from the injector according to preparation procedure for injecting contrast medium.The pressure tubing was connected firmly, and a contrast medium was filled to a cup.Before imaging, the doctor filled 10ml syringe with a contrast medium from the cup and started imaging (injection rate:2ml/sec, injection volume:5ml).Immediately after the imaging started, air inclusion was shown on the image and the doctor instructed to stop imaging and injection.After that, loosening of connector, leakage and air inclusion in the syringe were checked but were not confirmed.Patient demographic information requested but unavailable.The device was discarded by the hospital.

Manufacturer Narrative

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: 8833953
• MDR Text Key: 152787096
• Report Number: 2015691-2019-02785
• 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
• Report Date: 07/03/2019

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 Model Number: MP7212_
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1