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

Model Number 111F7P

Device Problem Separation Problem (4043)

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

Event Date 07/23/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Per the ifu specifications table, swan ganz model 777f8 should be used with a 9f introducer.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, during use of this swan ganz catheter, in a right heart angiogram study in a patient, the catheter balloon detached and remained inside the patient.The balloon was in one piece.Doctor did not want to conduct major surgery to retrieve the balloon.He felt that even if it did block a vessel of some sort, that blood would be redirected another way.Doctor and interventional radiologist used x-rays to try to find the balloon, hoping that it was still inflated.They injected contrast, but it did not help.They also did a contrast pump to see if it was suck anywhere.Then, they did a dsa (digital subtraction angiography), which did not help either.They concluded that it was hard to find, and the catheter balloon could not be located.Doctors feel it is safe to leave the balloon inside the patient and they hope that if it gets lodged somewhere, it will not cause a problem in the future because it is in a vein; it likely has gone to the limbs and not the heart.They spoke to the patient and gave assurance that there would not be a problem.The patient is recovering and being monitored.The rest of the product is expected to be returned for analysis; however, it has not yet been received.

Manufacturer Narrative

Per further follow up regarding event description, it was clarified that the balloon latex broke in one piece, which remained inside the patient.One swan-ganz catheter with 1.5cc syringe was received by our product evaluation laboratory for a full examination.The report of balloon issue was confirmed.As received, balloon was found to be torn and missing at the central area.The edges of the balloon did not match up.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from catheter body.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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.

Manufacturer Narrative

Based on engineering investigation and on the information available, it cannot be confirmed that the failure condition being evaluated is associated to the manufacturing, design process or that there was a product non-conformance that potentially contributed to the complaint.A product risk assessment was performed to address the balloon burst rupture condition.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: CATHETER, FLOW DIRECTED
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 12299769
• MDR Text Key: 265798577
• Report Number: 2015691-2021-04592
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: 111F7P
• Device Lot Number: 63417720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 101