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

Model Number 774F75

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

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.(b)(4).

Event Description

It was reported that the customer tightened the adapter of the contamination shield excessively after the operation at icu, and therefore ra (right atrium) pressure was increased more than expected.At that time proximal injectate lumen was connected to the blood pressure kit and ra pressure was monitored.The lumen was kinked due to over-tightening, and therefore they suspected it caused the occlusion of the lumen.The value of ra pressure became normal when the adapter of the contamination shield was loosened.The pulmonary artery (pa) pressure value had been normal.Occurrence date is unknown.There were no patient complications reported.Additional information was reported that the indicated cvp value was over 15mmhg, while the expected value was unknown.The value and waveform matched, the patient was not treated based on the incorrect value.The error message was not observed.The value was not affected by the patient condition.Patient demographic information requested but unavailable.

Manufacturer Narrative

One catheter with detached monoject 1.5 cc limited volume syringe and two three-way stopcocks were returned for evaluation.A non-edwards contamination shield was located on the catheter between 41.5 cm and 97 cm proximal from the catheter tip.Clotted blood was observed from the contamination shield.Without the return of the pressure monitoring unit, the customer report of pressure measurement issue could not be confirmed.All through lumens were patent without any leakage or occlusion.No resistance was felt when air or water was injected to the through lumens when the contamination shield was loosened or tightened.A lab 0.018" angle tip guidewire (as recommended in the ifu) was passed hub to tip and tip to hub without resistance when the contamination shield was loosened or tightened.After removing the contamination shield, three indentations were found at 42.5cm, 94.5 cm and 95cm.It was able to insert the catheter without resistance into a lab 8.5fr and 9fr introflex introducer which is the recommended size introducer per the ifu.No visible damage or inconsistency to the balloon, or returned syringe was observed.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.Balloon inflation testing was performed using returned syringe with 1.5 cc air and a calibrated stopwatch.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of pressure measurement issue could not be confirmed 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.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.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.In this case it is unknown whether any user or procedural factors may have contributed to the stated 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.No corrective or preventative actions are required at this time.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7042532
• MDR Text Key: 93048691
• Report Number: 2015691-2017-03923
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

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: 05/26/2019
• Device Model Number: 774F75
• Device Lot Number: 60890928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 12/03/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1