MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY

Model Number PE074F5

Device Problem Failure to Deflate (4060)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported that the balloon of a swan ganz could not be deflated during use.Catheter had to be cut to deflate the balloon.The patient was a 60 year old male with myocardial infarction and the catheter was used in coronary angiography with 5 fr sheath.Before the procedure, inflation test was performed with no problem.After the catheter was inserted, it was advanced to the right atrium however the customer could not deflate the balloon even after removing the syringe.Since there was no other option to deflate the balloon, the catheter was cut just above the connection site of the syringe, between the connection site and the backform.There was no patient injury associated with this event, and the patient recovered without problem after the procedure.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.

Manufacturer Narrative

A product evaluation was completed.The reported event of the balloon could not be deflated was not able to be confirmed during evaluation.As received, balloon extension tube was cut at 11.4 cm from y adaptor.No other visible damage or abnormality was observed from balloon, windings, catheter body, and returned syringe.No occlusion or leakage was observed between the gate valve and the cut section.With a tuohy borst connector, balloon was able to be inflated and deflated without issue.Seal in the gate valve was deformed.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Per product evaluation, the seal in the gate valve was deformed.The complaint failure is associated to a manufacturing, design defect.A device history record review was completed and documented that device met all specifications upon distribution.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18314654
• MDR Text Key: 330354505
• Report Number: 2015691-2023-18316
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PE074F5
• Device Lot Number: 65083095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2023
• 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: 60 YR
• Patient Sex: Male