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 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results, as well as the device history record review results when completed.

Event Description

It was reported that during use, this swan-ganz pacing catheter, model d97120f5, lot 6442043, would not capture.Another catheter was switched out for the suspect catheter and it worked immediately.There was no patient injury.

Manufacturer Narrative

A device history record review was completed and reported that the product passed with no nonconformances, but there was one ncr related to the subassembly verified wo number.During the stretching operation of bipolar regular products, the catheter tube from bumb tubing was breaking.A crushed, distorted, or otherwise damaged material is cause for rejection.Stretching is the first operation of the product, therefore, once the tubing breaks, the product is not manufacturable.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.A product risk analysis (pra) was generated earlier to cover full open and intermittent condition at the tip for bipolar pacing catheters.A corrective and preventive action (capa) was initiated to address the pacing catheters broken leadwire proximal failure for bipolar models, which have pacing difficulties, such as full, intermittent, and short conditions.

Manufacturer Narrative

One d97120f5 catheter with non-edwards contamination shield was returned for evaluation.The reported pacing issue was confirmed.Continuity testing confirmed a full open condition of the proximal circuit.The distal circuit was found to be continuous.An x-ray photo showed the lead wires were bunched near the catheter tip and the proximal lead wire was broken near the proximal electrode.The balloon inflated clear and concentric and remained inflated for five minutes without any leakage.The catheter body had an indentation at the location of the proximal connector of the non-edwards contamination shield.An engineering evaluation was completed 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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this 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 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: 15459545
• MDR Text Key: 301657253
• Report Number: 2015691-2022-07985
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)240629(11)220630(10)64432043
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2022

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 Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 64432043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 10/20/2022; 11/04/2022
• Supplement Dates FDA Received: 10/19/2022; 11/03/2022; 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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