MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

Model Number PE075F5

Device Problem Failure to Capture (1081)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that during use of a model pe075f5 swan ganz catheter in a percutaneous coronary intervention of the right coronary artery.No pacing response was received upon catheter insertion.The generator was replaced but the issue persisted.The issue was resolved by replacing the catheter.It is unknown if the patient had cardiac conduction defect.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3cc limited volume syringe.Clotted blood was observed from the catheter.As received, the catheter tip has an s shape.Continuity testing confirmed a full open condition in the distal circuit.The proximal circuit was found to be continuous.A cut down of the catheter body was performed just proximal side of the proximal electrode to expose the pacing lead wires.Continuity testing confirmed a full open condition around the catheter tip.It was also confirmed that the distal circuit was continuous from just proximal side of the proximal electrode to distal connector pin.The balloon inflated but failed to maintain its inflation due to leakage from a partial bond detachment between the proximal electrode and catheter body.No other visible damage or defect was observed from the balloon, windings, catheter body, and returned syringe.A device history review was initiated.Upon completion.A supplemental report will be sent with the investigation results.The customer report of a pacing issue was confirmed on evaluation.An engineering evaluation has been 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.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was previously generated to cover full open and intermittent condition at tip for bipolar pacing catheters for products nonconformance with moderate, major, or critical severity.Additionally, a capa was generated to address the pacing difficulty failure effect for bipolar products with full open, intermittent, and short conditions and is in the control phase.The root cause was related to manufacturing.Updates to the h6 codes are as follows investigation findings was changed to manufacturing process problem identified and investigation conclusions was changed to cause traced to manufacturing.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 device history record review was completed and documented that the device met all specifications upon distribution.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
• Type of Device: SWAN-GANZ BIPOLAR PACING
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 16715881
• MDR Text Key: 313255020
• Report Number: 2015691-2023-12250
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00690103008753
• UDI-Public: (01)00690103008753(17)241016(11)221017(10)64618319
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE075F5
• Device Lot Number: 64618319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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