MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRODUCT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO3906TS02PL_

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specification at the time of release.Unfortunately, we did not receive the sample for examination in our product evaluation laboratory.Without return of the product, we are unable to perform a complete investigation into the root cause of the reported event.At this time, we cannot confirm the reported issue.

Event Description

It was reported that hepatic venous pressure showed around 200mmhg shortly after using the device.The waveform and the value matched.However, the waveform was a straight line during the high value.The line was flushed with the syringe but the problem was not solved and the device was exchanged.Zeroing was performed with no issues and there were no occlusion, leaks or kinks noted.Also, no error message was shown on the nihon koden monitor.The expected value was around 15 to 20mmhg.There were no patient complications reported.Device will not be returned due to the infection therefore it is not available for evaluation.

• Brand Name: CUSTOM DEFINED PRODUCT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5306737
• MDR Text Key: 33767802
• Report Number: 2015691-2015-03413
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/25/2015

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: VO3906TS02PL_
• Device Lot Number: POSSIBLE LOT NO: FK0481MT, FL0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/17/2015
• 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