MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER; CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Pacing Problem (1439)

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

Event Type  malfunction  

Event Description

It was reported that during use with this swan-ganz bipolar pacing catheter (model: d97120f5, lot: 64687350) it was unable to pace.The issue was resolved by replacing the catheter.Information such as the background of malfunction occurrence, the phase when the catheter was unable to pace, what kind of surgery/examination the catheter was used for or if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The device has been returned but the product evaluation has not been completed yet.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.

Manufacturer Narrative

An engineering evaluation was completed to assess for any manufacturing-related processes which could be correlated to the complaint.A product risk analysis (pra) was generated earlier to cover full open and intermittent condition at the tip for bipolar pacing catheters.A corrective and preventive action (capa) was initiated to address the pacing catheters broken leadwire proximal failure for bipolar models, which have pacing difficulties, such as full, intermittent, and short conditions.Updates to the h6 codes are as follows investigation findings was changed to manufacturing process problem identified investigation conclusions was changed to cause traced to manufacturing.

Manufacturer Narrative

Our product evaluation lab received one model d97120f5 bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe.The reported pacing issue was confirmed.The distal circuit was found to be continuous.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing leadwires.It was observed that the proximal leadwire was broken at 1.8 cm proximal from catheter tip.It was also confirmed that the proximal circuit was continuous from broken lead wire to proximal connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for five minutes without leakage.There was no visible damage or defect observed from the balloon, windings and catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ BIPOLAR PACING 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, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17075767
• MDR Text Key: 316697849
• Report Number: 2015691-2023-13467
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822723
• 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,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 64687350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1