MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; FOGARTY CATHETER

Model Number D205F7

Device Problems Loose or Intermittent Connection (1371); Pacing Problem (1439)

Patient Problem Cardiac Arrest (1762)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the contamination shield of the swan ganz catheter was so loose that the catheter could not be fixed during surgery for mitral valvuloplasty (mvp) with da vinci surgical system.The catheter was unable to pace and cardiac arrest developed for approximately one minute.After the catheter position was changed, heart rate was recovered.No problem has been observed in the patient after the operation.There is no suspect of cerebral infarction.The patient did not have cardiac conduction defect.The customer commented that it is unknown whether the diameter of the catheter was small or the contamination shield was not tightened enough.

Manufacturer Narrative

One pacing catheter with attached monoject 1.5 cc limited volume syringe, two three-way stopcocks and coset kit was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 30 cm and 90 cm proximal from the catheter tip.A non-edwards introducer was returned detached from the catheter.Customer report of "unable to pace" could not be confirmed during the evaluation.When proximal and distal connectors of the non-edwards contamination shield were at lock position, the catheter body was found to move underneath the contamination shield and a gap was observed between the proximal connector of the contamination shield and the catheter body.Continuity testing was performed on the distal and proximal ventricular circuits and the distal, central and proximal atrial circuits.There were no open, intermittent, or short conditions observed.No visible damage or abnormality to the catheter body, balloon or returned syringe was observed.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.Further evaluation confirmed the report of "diameter of the catheter was small".The outer diameters of the catheter body were measured to be 0.0891", 0.0919" and 0.0915" at 40 cm, 60 cm and 90 cm from the catheter tip, respectively.The outer diameter at 40 cm is out of specification.The specification of the outer diameter of the body tube is 0.092" +0.003"/ -0.002".Balloon inflation test was performed using returned syringe with 1.5 cc air by holding the balloon under water for 5 minutes.Visual examinations were performed under microscope at 10x magnification and with the unaided eye.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.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.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported event.If using a contamination shield, extend the distal end towards the introducer valve.Extend the proximal end of the catheter contamination shield to the desired length, and secure.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

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9508629
• MDR Text Key: 183514561
• Report Number: 2015691-2019-04851
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• 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: 12/11/2019

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 Operator: Health Professional
• Device Model Number: D205F7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2019
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/22/2019
• Supplement Dates Manufacturer Received: 02/07/2020; 07/23/2020
• Supplement Dates FDA Received: 02/12/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR