MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER; SWAN-GANZ CATHETER

Model Number 774F75

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2020

Event Type  malfunction  

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.A device history record review was completed and documented that device met all specifications upon distribution.No actions will be taken at this time.

Event Description

It was reported that resistance was felt and the swan ganz catheter did not pass through a sheath introducer during insertion on the first day of use.A new insertion site was made and another introducer and catheter were used and the problem was solved.The customer commented that it could not be determined if the problem was on the introducer or the catheter.The manufacturer, the part number or the size of the introducer is unknown.There were no patient complications reported.Patient demographic information requested but unavailable.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.Introducer was not returned.No visible damage or inconsistency was observed from the catheter body, balloon, or returned syringe.It was able to insert the catheter without resistance into both lab 8.5fr and 9fr introflex introducers, which are the recommended size introducer per japan ifu.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Further evaluation found that the maximum outer diameter of the catheter body was at the distal thermal filament cover bond and was measured to be out of specification, at 0.108".The maximum outer diameter thru the heater section is 0.105".Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 10x magnification and with the unaided eye.Customer report could not be confirmed during the analysis; however, the maximum outer diameter of the catheter body was found to be out of specification.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this instance, the patient required a new stick during the procedure to insert a new access device and catheter, this is a reportable event.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: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• 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: 9970429
• MDR Text Key: 188672360
• Report Number: 2015691-2020-11495
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• 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: 04/01/2020

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 Expiration Date: 12/09/2021
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 62840947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/29/2020; 07/23/2020
• Supplement Dates FDA Received: 05/14/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1