MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH; PACING CATHETER

Model Number TOE135F75

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

The device evaluation is in progress.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.

Event Description

It was reported that it was difficult to remove the swan ganz catheter on the second day of use in a (b)(6) year old male patient.The catheter was used for aortic valve replacement (avr) and mitral valve replacement (mvr).After avr and mvr, bleeding was observed at the closed site of right atrium (ra).The bleeding site was stitched, and then, the operation was completed.The catheter was attempted to be removed in the icu on the second day of use, however, there was resistance felt and it was unable to remove.The chest was reopened and the catheter was removed successfully.It was likely that the catheter was got stitched on ra by accident.The severity is determined by the doctor as non-serious.The patient's outcome was reported as recovered.The customer considered that the event was unlikely related to the device malfunction.

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and two three-way stopcocks was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 92.7 cm and 111 cm proximal from the catheter tip.The contamination shield was removed for evaluation.Two punctures were found on opposite sides of the catheter body, located at 28.8cm from the catheter tip.The size of the punctures were approximately 0.5mm and <0.5mm.Visual examination also found that the catheter body was collapsed at 94.5cm from the catheter tip.Clotted blood was observed inside the thermistor connector.Leakage was observed from both punctures when air was injected into the thermistor lumen and fiber lumen.No other visible damage to the balloon, catheter body, or returned syringe was found.The balloon inflated clear and concentric, and remained inflated for 5minutes without leakage.Distal lumen and proximal injectate lumen were patent without any leakage or occlusion.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report was confirmed during the analysis.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.Per the reporting clinician, the reporter stated that the most likely cause was that the catheter was inadvertently sutured to the ra during a surgical procedure.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 PACING THERMODILUTION O2 SAT CATHETER FOR USE WITH SAT-2 COMPUTER WITH
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9129426
• MDR Text Key: 162993645
• Report Number: 2015691-2019-03603
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: TOE135F75
• Device Lot Number: 62132859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 09/27/2019; 07/23/2020
• Supplement Dates FDA Received: 10/22/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 53