MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 746F8

Device Problem Deflation Problem (1149)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

One 746f8 catheter with attached monoject 1.5 cc limited volume syringe, bd 5 ml syringe, and 2 three-way stopcocks was received.The reported issue that it was unable to deflate the balloon was not able to be confirmed due to the balloon rupture.The balloon was found to be ruptured at central area of balloon latex and the rupture edges were not able to match up.No resistance was felt when air was injected into balloon inflation lumen.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body and returned syringe.Per the ifu, "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures." and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume and pull force for each size catheter." an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that during use with this swan-ganz catheter, it was unable to deflate the balloon.It is unknown whether the inflation syringe was removed from the gate valve or not.The customer was able to deflate the balloon by pulling and pushing the plunger multiple times.After the catheter was removed, it was found that the balloon would not inflate.The patient demographic information was requested but not available.There were no patient complications reported.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.The product passed without a nonconformance reported on the device history record.The balloon wo number was verified and there is a ncr related to it.Non conformance description: on 03.26.2020 - 03.27.2020 during production of latex balloons, humidity deviated from 50 plus or minus 5% rh spec per section 11 in mi1033 revision do for cc latex balloons in irvine ca.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12615710
• MDR Text Key: 276676260
• Report Number: 2015691-2021-05628
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 63378525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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