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

Model Number D97120F5

Device Problem No Pacing (3268)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during use for a tavi procedure in the cath-lab, when connected the distal and proximal connector of this bi-pacing swan ganz catheter to the programmer, there was no pacing.However, the insertion and placement was done without any problems.As troubleshooting, the connections and the programmer were checked, but the issue remained the same.The issue was solved removing the catheter and placing a new one, which worked without any issues on the same programmer.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

As per product evaluation performed, the customer report of pacing issue was confirmed.Based on further investigation performed by the engineers at the manufacturing site, it cannot be confirmed that this complaint is associated to a manufacturing/design defect.The manufacturing process for bi-polar models includes controls to mitigate continuity issues.Nevertheless, an acknowledgment was provided to the manufacturing personnel regarding this condition.A product risk assessment was performed to address the condition of "cc intermittent condition at tip - distal electrode-pacing catheter" for bi-polar models.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 part of this monthly review.

Manufacturer Narrative

Additional information was received that patient demographics unable to be obtained.In addition, the manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met, and inspections passed successfully.Furthermore, the manufacturing and expiration dates were added according to the device history record review.One pacing catheter was received by our product evaluation laboratory for a full examination.As received, a 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 of the distal circuit around catheter tip.It was also confirmed that the distal circuit was continuous from just proximal side of the proximal electrode to distal connector pin.Then, the balloon inflated clear and concentric with 1.3 cc air and remained inflated for five minutes without leakage.No other visible damage or defect was observed from the balloon, windings, catheter body, and the returned syringe.Based on this, the customer report of pacing issue was confirmed.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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 part of this monthly review.

• Brand Name: CATHETER, FLOW DIRECTED
• Type of Device: SWAN-GANZ BIPOLAR PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13998839
• MDR Text Key: 297347240
• Report Number: 2015691-2022-04811
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2023
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 64056570
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2021
• 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