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

Model Number PX260

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

As reported, in this disposable pressure transducer (dpt), the three-way stopcock broke while trying to move it.Small pieces, shards of plastic, were left inside the lumen.The dpt was exchanged.There was no patient injury as a result of this issue; the incident occurred before use.However, the user alleges risk of embolization in the artery line and ischemia of the hand.No other details have been provided.

Manufacturer Narrative

Device not yet returned; evaluation anticipated.Additional manufacturer narrative: the reported issue has the potential for embolization if the pieces enter the fluid path.The subject device has not been returned at this time.A supplemental report with our findings will be submitted once the device is returned and evaluated.No further actions possible at this time.

Manufacturer Narrative

Evaluation summary: damage was found at stand-alone stopcock and pressure tubing connection.The stopcock male luer had been broken and part of the broken luer stuck inside mating pressure tubing female connector.The broken male luer had been twisted.Indications of what appeared to be bonding material were found on both broken luer and tubing female connector.It seemed tubing female connector had been bonded to the stopcock.It was determined that bonding between the stand-alone stopcock and pressure tubing female connector should not have occurred.Attempts to disconnect this connection had caused damage to the stopcock male luer.The reported issue was confirmed through evaluation of the subject device.Continued investigation is still in progress to determine root cause and any necessary corrective actions.A supplemental report will be submitted for any new information.

• Brand Name: PHOENIX DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; ms: jamb b 2; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4738067
• MDR Text Key: 5828788
• Report Number: 2015691-2015-00970
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

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: PX260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 04/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 7 YR
• Patient Weight: 17