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

Model Number D97130F5

Device Problem Failure to Capture (1081)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.A device history record review was completed and documented that the device met all specifications upon distribution.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.

Event Description

It was reported during a procedure, a swan ganz catheter model d97130f5, lot 64582423, did not function by lack of visual pacer spikes.Troubleshooting included a cable change, pacer box changes and they changed out for new temporary pacemaker catheter and the new one worked fine.There was no allegation of patient injury.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A capa was generated for further investigation on the pacing difficulty failure effect for bipolar products with full open, intermittent, and short conditions.The capa is currently in the control phase.Additionally, a product risk assessment was generated to cover the full open and intermittent condition at the tip for bipolar pacing catheters for product nonconformances with moderate, major, or critical severity.The ifu provides instructions to ensure the electrode condition prior catheter insertion.Per the warning section, this catheter requires special techniques for insertion and removal.Electrode dislodgement may result from pulling the catheter out through the percutaneous sheath.Additional precautions are outlined to avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry, and since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.

Manufacturer Narrative

Our product evaluation lab received one model d97130f5 catheter with a 1.3ml monoject limited volume syringe.The distal circuit was found to be continuous.Cut down on the catheter body found the proximal lead wire was broken at approximately 1.8 cm proximal of the distal tip.Insulation was not present on the lead wire at the location of the damage.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.No visible damage or inconsistency was observed from the catheter.The customer report of a pacing issue was confirmed on evaluation, as continuity testing confirmed a full open condition of the proximal circuit.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)
• Type of Device: SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION)
• 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: 16042915
• MDR Text Key: 306090099
• Report Number: 2015691-2022-10277
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Device Lot Number: 64582423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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 Age: 85 YR
• Patient Sex: Male