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

Model Number PE075F5

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of balloon inflation difficulties was not able to be confirmed.As received, the balloon latex, distal and proximal windings were completely missing and not returned.Residual adhesive was not observed from the distal electrode and distal side of catheter tube.Adhesive was found on the proximal electrode and catheter body around proximal leadwire but it appeared to be an adhesive for proximal leadwire bonding and not for balloon attachment.No visible damage was found from catheter body.Further evaluation regarding related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.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.

Event Description

It was reported that the balloon of a swan ganz catheter did not inflate before use.Product was returned and balloon latex, distal and proximal windings were completely missing and not returned.Additional information were obtained from the sales rep after product evaluation was performed.Detachment of the balloon was not reported from the customer although they would likely have noticed if the balloon was detached.Even if balloon inflation issue is observed during balloon test, the balloon is not always verified closely by the customer.Therefore, there is a possibility that the customer does not notice if the balloon was missing initially.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL 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: 15894737
• MDR Text Key: 306448082
• Report Number: 2015691-2022-09584
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PE075F5
• Device Lot Number: 64481575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2022
• 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