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

Model Number 896083L1B

Device Problems Incorrect Measurement (1383); Low Readings (2460)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results as well as the device history record.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 this truwave cable was giving intermittent low pressure readings.The cable was working initially, but after 20 minutes it began to give incorrect systolic readings.The disposable pressure transducer and the cable were replaced and then the measurements were as expected.The sales representative was unable to obtain the lot number or any further information regarding this issue.There is no allegation of patient injury reported.Patient demographics unable to be obtained at this time.The cable was available for evaluation.

Manufacturer Narrative

Through investigation it was found that this event does not meet the criteria for a complaint.It was communicated by the customer that the event was not caused by the truwave cable or another edwards device, therefore, there is no evidence or allegation that the use/misuse or malfunction of an edwards device caused or contributed to the event.Further information could not be obtained from the customer.The product will not be returned for evaluation.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: TRUWAVE
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9370857
• MDR Text Key: 189490804
• Report Number: 2015691-2019-04391
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K142749
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 896083L1B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1