MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ BIPOLAR PACING CATHETER; CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Pacing Problem (1439)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

Event Description

It was reported a swan ganz pacing catheter was unable to pace from the beginning of use.The issue was resolved by replacing the catheter.Information such as the background of malfunction occurrence, surgery or examination the catheter was used for, and if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported event of pacing issue was confirmed.Continuity testing confirmed a full open condition of the proximal circuit and the distal circuit.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.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing leadwires.The proximal and distal leadwires were found to be broken and detached around catheter tip.It was found that both proximal and distal circuits were continuous from broken and detached section to connector pin.After cutting the balloon, it was confirmed that the proximal leadwire was broken at the proximal electrode port.Further evaluation regarding supplier related quality issues is under investigation.Lot number was obtained per the label included in the returned product and a device history record review was completed.Device met all specifications upon distribution.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 a part of the monthly review.

Manufacturer Narrative

Engineering evaluation was completed.A capa was initiated for this issue and a product risk assessment was needed.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 a part of the monthly review.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15008385
• MDR Text Key: 301644830
• Report Number: 2015691-2022-06758
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/14/2023
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• 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: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• 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