MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 111F7

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.Another possible lot number was provided 60126433 the manufacturing date: 07/29/2015 ,the expiration date: 08/04/2017.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

As reported, when testing the catheter prior to use, the balloon did not deflate with the syringe not attached to the gate valve.Finally, replacing the catheter for another solved the issue.There was no allegation of patient injury.Unfortunately, the sample is not available for evaluation as it was discarded by the hospital.

• Brand Name: SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5345267
• MDR Text Key: 35111355
• Report Number: 2015691-2016-00020
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PREAMENDMENT
• 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: 12/15/2015

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 Expiration Date: 08/04/2017
• Device Model Number: 111F7
• Device Lot Number: 60122879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2015
• 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