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

Model Number PE074F5

Device Problem Pacing Problem (1439)

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

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.Device not returned.

Event Description

It was reported that on the first day of use, a defect was found on the lumen and it was unable to pace.Additional information such as, the phase when the catheter was unable to pace, what kind of surgery/examination the catheter was used for, if the patient had cardiac conduction defect, or if any action was taken for the issue is unknown.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter with attached non-edwards introducer between 76 cm and 90 cm proximal from the tip and an attached monoject volume limited 1.3 cc syringe at gate valve was returned for examination.There was clotted blood observed inside the catheter.The reported event of a defect found on the lumen was confirmed but the pacing issue was unable to be confirmed.There was no visible damage observed on the balloon or windings.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.There was clotted blood observed inside the balloon.Partial bond detachment was found between proximal electrode and the catheter body.The sample was sent for further evaluation.The balloon was inflated with tuohy borst connector and the returned syringe.The balloon was unable to stay inflated due to leakage through the partial bond detachment.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• 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: 12756091
• MDR Text Key: 285047619
• Report Number: 2015691-2021-06157
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: PE074F5
• Device Lot Number: 63374464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1