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

Model Number PX260

Device Problems Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

Follow-up is ongoing for device availability.The complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided; therefore, review of the manufacturing records could not be completed.

Event Description

It was reported that during use, a leak was noticed in the disposable pressure transducer (dpt).In addition, the clinician stated that inaccurate values were obtained during use of this dpt.The product was exchanged the problem was solved.There is no demographic information available at this time.

Manufacturer Narrative

Per additional follow-up with the hospital, it was clarified that there were no inaccurate values during the reported event.It was discovered that the physician¿s initial statement that leakage in the dpt housing led to inaccuracy of the pressure data, was a statement based on assumption and not a statement of fact.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

Corrected data: f10, h6.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: 8186963
• MDR Text Key: 131324374
• Report Number: 2015691-2018-05489
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

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: PX260
• Device Catalogue Number: PX260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 12/24/2018; 07/23/2020
• Supplement Dates FDA Received: 01/08/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1