MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774HF75

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

We were not able to obtain additional information as this is an anonymous complaint captured by (b)(4).The device was not returned for evaluation.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.

Event Description

It was reported that when testing prior to use, the balloon did not deflate.The customer tried with another catheter to solve the problem.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.It was further indicated that the customer does not completely detach the syringe.They release the syringe from the gate valve without taking it off completely.As stated in the ifu ¿passively deflate the balloon by removing the syringe from the gate valve¿.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5815817
• MDR Text Key: 50403146
• Report Number: 2015691-2016-02311
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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: 04/07/2017
• Device Model Number: 774HF75
• Device Lot Number: 60201244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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