MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH CONTAMINATION; CATHETER, FLOW DIRECTED

Model Number 831VF75P

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that when the nurse handed a patient over after a coronary artery bypass surgery (cabg), leakage of blood and propofol of approximately 5-10 ml was observed within the plastic sterile casing enclosing the external part of the catheter.Additionally, the catheter displayed a dampened waveform and no evidence that the balloon inflated.The catheter had incorrect temperature reading of 44.9 ºc.The device was inserted to 38 cm at the tip of the sheath of the swan ganz catheter and its correct placement in the pulmonary artery was confirmed by chest x ray.The swan ganz catheter had been used during the surgery to administrate medication; however, the port used was not remembered and there was no evidence of propofol in any of the ports.The swan ganz catheter was removed keeping the introducer in place.As per customer¿s opinion the issue might be related to the incorrect port used for drug administration, or to a proximal aperture above sheath or to a defect in the device.There was no allegation of patient injury.The device is available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

Follow up with the customer indicated that the blood and propofol was within the contamination shield.The expected blood temperature was 36-37 degrees.A review of the manufacturing records indicated that the product met specifications upon release.Added the patient demographics.

Manufacturer Narrative

One 831vf75p swan-ganz catheter with a 1.5cc syringe and non-ew contamination shield were returned for examination.The reported event of temperature measurement issue and blood leakage were not confirmed.As received, dry blood residues were noticed at the thermistor connector.No fault messages showed up on the lab vigilance ii monitor when the catheter was connected.The thermistor was found to read 37.0 c when submerged into a 37.0 c water bath.The thermistor temperature reading accuracy is +/- 0.3 c per the vigilance ii manual.The thermistor circuit was continuous, there were no open or intermittent conditions.The thermistor connector was opened, no visible blood residues were noticed in the inside.In addition, there was no visible damage or inconsistency observed from the catheter body, connectors, balloon or the returned syringe.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.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.Medication not being delivered consistently could cause a deterioration in the patient¿s condition and may necessitate additional interventions.It is unknown whether user or procedural factors contributed to the stated event.In this case, the customer indicated that the issue might be related to the incorrect port being used for drug administration.As part of the manufacturing process, 100% of the units go through a leak and flow test to verify lumen patency and detect catheter leakage.It should be noted that the ifu contains instructions to verity lumens patency and electrical continuity prior catheter insertion.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: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH CONTAMINATION
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 10563417
• MDR Text Key: 207933425
• Report Number: 2015691-2020-13668
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• 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: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 831VF75P
• Device Catalogue Number: 831VF75P
• Device Lot Number: 62042963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 61