MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ PACEPORT OXIMETRY TD CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 780F75M

Device Problems Leak/Splash (1354); Incorrect Measurement (1383); Increase in Pressure (1491)

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

Event Date 05/29/2019

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

Event Description

It was reported that the balloon tip on a swan-ganz catheter was noted to be leaking prior to insertion in the or; therefore, another swan-ganz catheter was used.Everything worked fine until 30 minutes post-operatively when the pulmonary artery pressures (pap) readings in the icu were noted to be extremely high on the monitor.Given the patient's status and monitor reading from the or, the pulmonary systolic pressure should have been around 40mmhg; however, the icu reading was in the 100s.The pulmonary and right ventricular pressures were thought to be inaccurate as it was physiologically improbable that the pap went from the 40s to 100s in 30 minutes with no other signs of systemic compromise.There were no error messages displayed.It was thought that the unexpected readings were caused by catheter displacement, but a chest x-ray confirmed proper positioning without coiling.They tried to advance and pull back the catheter tip ¿by a bit¿ to see if the readings changed, but when they inflated the balloon and let go without locking the syringe, they realized there was no air pushing the syringe back.Therefore, it was believed that there was a leak in the balloon.The customer did not feel that the balloon had burst but only that a leak had probably developed when the patient was transferred from the or to the icu.No harm was caused and no intervention was needed except for the removal of the suspect swan-ganz catheter.The lot number was unknown.

Manufacturer Narrative

Our product evaluation laboratory received one model 780f75m swan-ganz catheter with contamination shield and 10cc syringe.Visual examination found a 0.1inch long cut on the catheter body at located approximately 31cm proximal of the distal tip, causing leakage through the inflation lumen, distal lumen and rv pacing/infusion lumen.The balloon appeared to be in good condition.The proximal injectate lumen was patent without any leakage or occlusion.No fault messages showed up on the lab¿s vigilance ii monitor when the catheter was connected.The thermistor was read 37°c when submerged into a 37.0°c water bath.The thermistor temperature reading was within specified accuracy, per the vigilance manual.The catheter passed in-vitro calibration with the lab cal-cup.The customer report of balloon leakage and a pressure issue was confirmed due to catheter body damage.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 are well described in the literature.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure tubing that is used with the swan-ganz catheters can also be a contributing factor to inaccurate values.It should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient¿s clinical manifestations.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 PACEPORT OXIMETRY TD CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8729193
• MDR Text Key: 149224697
• Report Number: 2015691-2019-02305
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K905458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 780F75M
• Device Catalogue Number: 780F75M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 77