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

Model Number 97130F5

Device Problem Failure to Capture (1081)

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

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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 that during a transcatheter aortic valve replacement case, an edwards swan ganz temporary pacemaker catheter, model 97130f5, 5french was used.After positioning the temporary pacemaker in the right ventricle, the team attempted to test the pacemaker.Despite being well-positioned, the pacemaker did not work.All connections and cables were checked, and there did not appear to be anything amiss.A new edwards pacemaker catheter was opened and used without incident and the valve was successfully implanted without central leak.There were no allegations of patient injury.

Manufacturer Narrative

Customer report of pacing issue was confirmed.An engineering evaluation was completed to assess for any manufacturing-related processes which could be correlated to the complaint.A pra was generated to cover full open and intermittent condition at tip for bipolar pacing catheters for products nonconformance with moderate, major, or critical severity.

Manufacturer Narrative

Our product evaluation lab received one swan ganz catheter, model d97130f5 with monoject limited volume syringe.Customer report of pacing issue was confirmed.Continuity testing confirmed a full open condition of the proximal circuit and the distal circuit.Cut down of the catheter body was performed to expose the pacing lead wires.Distal leadwire was found to be broken at the solder.Proximal leadwire was broken at approximately 1.1cm proximal from distal tip.No visible damage or abnormality was observed from catheter body, balloon, windings and returned syringe.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 min without leakage.

• 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: 16036077
• MDR Text Key: 307459079
• Report Number: 2015691-2022-10279
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97130F5
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• 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