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

Model Number D97120F5

Device Problem Unable to Obtain Readings (1516)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

As reported, during use, this swan-ganz pacing catheter did not provide signal ((b)(4)).The catheter was replaced by another one from a different lot number and same issue occurred ((b)(4)).Using a third catheter the issue was solved.There is no allegation of patient injury.The devices were available for evaluation.

Manufacturer Narrative

One swan-ganz catheter was received at our product evaluation laboratory for a full examination.As received, customer report of "there was no signal" was confirmed.Continuity testing confirmed a full open condition of the proximal circuit.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 lead wires.The proximal lead wire was found to be broken.Insulation was not present on the lead wire at the location of damage.It was confirmed that the proximal circuit was continuous from broken lead wire to proximal connector pin.The balloon inflated clear and concentric and remained inflated for a period of time without leakage.No visible damage or inconsistency was observed from catheter.Further investigation was completed by the engineers in the manufacturing site and it could be confirmed that the root cause is likely due to manufacturing.Corrective actions are being in order to eliminate the cause of the non-conformity and prevent recurrence of this type of 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: 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18128708
• MDR Text Key: 328276327
• Report Number: 2015691-2023-17477
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Lot Number: 64482406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1