MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER

Model Number 777F8

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received to product evaluation.Upon the return of the product a supplemental report will be sent with the investigation results.Upon the device history record review results, a supplemental report will be sent.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that a swan ganz catheter model 777f8, lot 64470783 was inserted, the balloon would not deflate.Prior to insertion the balloon was tested and inflated and deflated as expected.During insertion, the physician noted the balloon would not deflate.When the balloon was removed, the balloon remained inflated.Troubleshooting included removing the syringe, repositioning the catheter, manually trying to pull back on syringe to remove air.The introducer used was a teleflex mac, multi lumen access catheter, 9french.The monitor was a hemosphere.There was no patient injury.

Manufacturer Narrative

Our product lab received one model 777f8 swan-ganz catheter with an attached monoject limited volume syringe.The balloon inflated clear and concentric, and remained inflated for 5 timed minutes without leakage.No visible damage or deterioration was found from the balloon latex and balloon bonding sites.The balloon deflated within 2 seconds without the syringe, which was within specification for the maximum deflation time from full capacity.The ifu states to passively deflate the balloon by removing the syringe from the gate valve.All through lumens were patent without leakage or any sign of occlusion.No visible damage was observed from the catheter body.The customer report of balloon would not deflate was not able to be confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15992391
• MDR Text Key: 306452407
• Report Number: 2015691-2022-10042
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240627(11)220628(10)64470783
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64470783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2022
• 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