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

Model Number PE075F5

Device Problem Pacing Problem (1439)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event of an incorrect device packaging of the pacing catheter was confirmed in the as received condition.Photos provided from the customer showed the labels on the shelf box and the tyvek described pe075f5 and a catheter with din adapters.As received, the labels on the shelf box and the tyvek described pe075f5.However, it was confirmed that the type of connector and tip of the catheter was different from that of the pe075f5 model.Received catheter contained two din adapters.It was also confirmed that the y adapter of the returned catheter did not have a label.No visible damage was observed from catheter body, balloon, windings and returned syringe.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 min.Without leakage.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.Per additional evaluation, the outer diameters of distal and proximal electrodes were measured to be 0.0734 in.And 0.0729 in.Respectively.The outer diameters of the electrodes aligned to that of a d97130f5 catheter.Further evaluation regarding related quality issues is under investigation.A capa was opened and is in the investigation phase in reference to the wrong device in package.Additionally, a product risk assessment was initiated to assess risk to patient.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 an incorrect device packaging of a pacing catheter was detected after the catheter insertion on the first day of use.Although the model number of the labels on the shelf box and the tyvek described pe075f5, the catheter packaged in the tray appeared to be d97130f5.The catheter was inserted from the femoral vein for a preventive measurement as a backup during rotablator procedure of percutaneous coronary intervention in the segment no.7 of left coronary artery.When the customer attempted to connect the pin connectors to an external pacemaker with an alligator clip, the pin connectors could not be connected to the pacemaker since din adapters were required to connect.The catheter was removed and zeon medical catheter was reinserted.No new insertion site was required and the procedure was performed successfully.The patient was male and other demographic information was unavailable.Per the sales rep, the physician got confused when the incorrect device was noted during the procedure.There were no patient complications reported.Additional information was obtained from the sales rep.Pci was performed on a scheduled date and it was non urgent.2 catheters with the same model and lot number in total were shipped to this facility, and it was confirmed that the correct device, pe075f5, was contained in the other package.Following information was obtained from supply chain, 197 catheters in total with the same model and lot number have been received and all of them have been delivered to facilities remaining 0 in stock at japan warehouses.Supply chain confirmed neither d97120f5 nor d97130f5 has been delivered to this facility since january 1, 2021.The sales rep noted that further detailed information regarding the procedure could not be obtained.Per the sales rep, balloon integrity should be verified before the catheter insertion.However, it was unable to confirm whether other verifications of devices are performed or required.

Manufacturer Narrative

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.

• 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: 15780103
• MDR Text Key: 306447133
• Report Number: 2015691-2022-09189
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PE075F5
• Device Lot Number: 64372601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2022
• 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
• Patient Sex: Male