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

Model Number TRUCLIP

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/09/2015

Event Type  Injury  

Event Description

A pediatric patient was brought to the operating room for surgery.The surgeon requested that all invasive lines be zeroed to the level of the heart.The truclip holder was adjusted to the appropriate height until the line on the field read 0 mmhg.Over the next 25 minutes that patients hemodynamic numbers began to fluctuate, and the patient was treated for the unstable readings, with no change in the patient status.It was discovered that the arterial line tubing was partially pinched in the truclip holder.The tubing was released and the patients hemodynamics returned to baseline.

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.A supplemental report will be sent when the investigation is complete.

Manufacturer Narrative

Received one truclip holder and one unknown tubing in a sealed package was returned for evaluation.Examination revealed no visible damage or defect was observed from the returned truclip unit.The truclip opened and closed without any problem.The truclip holders were provided to customer without any attached tubing or pressure monitoring kit per drawing (b)(4) for model truclip.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

• Brand Name: TRUCLIP
• 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: 4488564
• MDR Text Key: 5566492
• Report Number: 2015691-2015-00233
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

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 Model Number: TRUCLIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 02/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1