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

Model Number PE075F5

Device Problem Pacing Problem (1439)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that there was no pacing response received when the catheter was connected to the external pacemaker before use.The catheter was replaced and the problem was solved.The catheter was used for percutaneous coronary intervention (pci).It is unknown if the patient had cardiac conduction defect.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter with an attached monoject 1.3 cc limited volume syringe at gate valve were returned for examination.The reported event of pacing issue was confirmed.Balloon inflation issue was also confirmed.The balloon inflated but failed to maintain its inflation due to leakage from a partial bond detachment between the proximal electrode and catheter body.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 of the proximal electrode to expose the pacing lead wires.The distal lead wire was found to be broken around the solder joint.It was found that the distal circuit was continuous from broken lead wire to distal connector pin.No visible damage or defect was observed from the balloon, windings and returned syringe.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.However, it should be noted that the catheter had reached its expiration date when in use.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.Stretching, kinking, or forceful wiping of the catheter may result in damage.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.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 FOR FEMORAL INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 12058510
• MDR Text Key: 258087682
• Report Number: 2015691-2021-03756
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: PE075F5
• Device Lot Number: 62290516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1