MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 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 Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with an attached monoject volume limited 1.3 cc syringe at the gate valve was returned for examination.The reported event of a pacing issue was confirmed.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.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.There was no visible damage or defect observed from the balloon, windings, catheter body, and returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing 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.

Event Description

It was reported that when the customer performed the pacing test, this swan-ganz bipolar pacing catheter was unable to pace from the beginning of use during a tavi procedure.The catheter was replaced to zeon catheter and the problem was solved.It is unknown if the patient had cardiac conduction defect.Patient demographic information was requested but unavailable.There were no patient complications reported.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12481362
• MDR Text Key: 271722476
• Report Number: 2015691-2021-05209
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 63738592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2021
• 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