MAUDE Adverse Event Report: EDWARDS LIFESCIENCES TRANSLUMINAL BIPOLAR PACING PROBE; SWAN-GANZ BIPOLAR PACING CATHETER

Model Number PE075F5

Device Problem Pacing Problem (1439)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing non-conformance, failure mode, root cause, or potential contributing factors be identified.A device history record review was initiated to document whether the device met all specifications upon distribution.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 that a pe075f5 swan-ganz bipolar pacing catheter was unable to sense an intrinsic electrical signal from the beginning of use when the catheter was inserted into the right ventricle.The cable and external pacemaker were replaced, but the issue persisted.The issue was resolved by replacing the catheter.There were no patient complications reported.

Manufacturer Narrative

A supplemental mdr is being submitted due to the engineering evaluation findings.Sections g6, h2 and h6 - type of investigation findings, investigation findings and investigation conclusions have been updated.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation was performed for the condition of pacing failure for the bipolar pacing catheters.A capa was initiated and determined that the condition of full open, intermittent and short conditions with the bipolar pacing catheters is due to manufacturing issues related to manpower and insufficient instructions.The capa is currently in the control phase.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.

Manufacturer Narrative

Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe.Continuity testing found that the distal and proximal circuits had an intermittent condition when flexing the tip area of the catheter.No short condition was observed between the proximal and distal lead wires.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 an intermittent condition of the distal and proximal circuits 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, and the proximal circuit was continuous from just proximal side of the proximal electrode to proximal connector pin.The balloon inflated clear and concentric and remained inflated for 5 min.Without leakage.No visible damage was observed from windings, balloon, catheter body, and returned syringe.Customer report of sensing issue was confirmed.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.

• Brand Name: TRANSLUMINAL BIPOLAR PACING PROBE
• Type of Device: SWAN-GANZ BIPOLAR PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 17230982
• MDR Text Key: 318342909
• Report Number: 2015691-2023-14261
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

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: 64676465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 06/30/2023; 09/01/2023
• Supplement Dates FDA Received: 07/17/2023; 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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