MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER

Model Number D97120F5

Device Problem Failure to Capture (1081)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model d97120f5.Continuity testing confirmed a full open condition of the proximal circuit.The distal circuit was found to be continuous.Catheter body was found cut by the proximal lead wire at the lead wire port.The cut was 0.03" long.Cut down was performed on the balloon and catheter body near the proximal electrode.Proximal lead wire was broken near the port.The tip of the broken leadwire was tapered.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.No visible damage was observed from catheter body.The customer report of the pacer catheter not capturing was confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A device history record review was completed and documented that 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 swan ganz pacer catheter model d97120f5, lot 64532614, was found defective and did not capture during the procedure.Changing the pacer swan resolved the issue.There was no patient injury.There was no delay in the case.

Manufacturer Narrative

It is noted that medwatch report 2015691 2023 10602 previously reported an incorrect aware date of 02/02/2023.This report is to provide the correct aware date as 12/15/2022, which was the date the customer provided additional information that identified the issue to be reportable.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A product risk assessment was completed to cover full open and intermittent condition at the tip for bipolar pacing catheters.Additionally, a capa was generated to investigate the pacing difficulty failure effect for bipolar products with full open, intermittent, and short conditions.The ifu provides instructions to ensure electrode condition prior catheter insertion.As per the warning: this catheter requires special techniques for insertion and removal.Electrode dislodgement may result from pulling the catheter out through the percutaneous sheath.Precaution: avoid forceful wiping or stretching of the catheter during testing and cleaning as not to break the electrode wire circuitry.Precaution: 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.

Manufacturer Narrative

Our product lab received one model d97120f5 catheter with monoject limited volume syringe.Continuity testing confirmed a full open condition of the proximal circuit.The distal circuit was found to be continuous.The catheter body was found cut by the proximal leadwire at the leadwire port.The cut was 0.03 inches long.Cut down was performed on the balloon and catheter body near the proximal electrode.The proximal lead wire was broken near the port.The tip of the broken leadwire was tapered.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.The customer report of a pacing issue was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER
• Type of Device: SWAN-GANZ BIPOLAR PACING CATHETER
• 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: 16304787
• MDR Text Key: 308936555
• Report Number: 2015691-2023-10602
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)240824(11)220825(10)64532614
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 64532614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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