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

Model Number 777F8

Device Problems Material Frayed (1262); Incorrect Measurement (1383); Overheating of Device (1437); Material Split, Cut or Torn (4008)

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

Event Date 01/21/2019

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.Reference mdr #2015691-2019-00387 for the concomitant product, oxsc cable.

Event Description

It was reported by the cvicu night charge nurse that during use of a swan-ganz catheter, the hemoxsc100 cable overheated to the point that it caused damage to the catheter.According to the reporting nurse, it caused an internal wire between the blue tab and the catheter to ¿fray and split¿ and they were unable to get hourly svo2 numbers, which are documented once in the morning when it is calibrated.The edwards sales representative (ew rep) visited the customer facility and met with the supervising unit manager to further investigate the event.The supervisor re-iterated the complaint as reported but added that after the damage was discovered, the catheter continued to be used throughout the night.The reporting nurse did not look at the monitor, so it is unknown if any alarms or error messages were displayed at any time prior to, during, or after the reported damage was discovered.The supervisor also clarified that they re-calibrate the catheters every morning, and in this instance, when the swan-ganz catheter was re-calibrated the values were felt to be accurate, though it was noted that whenever the oximetry cable was moved, the svo2 values would inaccurately increase into the 80¿s ¿ 90¿s.This would occur without any change in patient positioning or condition.Once again, despite the noted inaccuracies upon movement of the cable, they still continued to use the catheter until it was removed that afternoon.There was no patient injury or treatment provided as a result of the reported issues.Lastly, the ew rep examined the suspect cable and catheter with the supervising rn, and they both agreed that the damage appeared to have occurred at the om connector from ¿a lot of tension¿ on the catheter; however, since the night shift nurse had reported that the damage to the swan-ganz catheter had been caused by the overheated cable, the exact cause of the damage on the catheter could not be confirmed.The lot number was unknown.

Manufacturer Narrative

Our product evaluation laboratory received one model 777f8 catheter with a monoject limited volume syringe and a non-edwards contamination shield.There was no visible abnormality associated to excessive heat on the connector housing; however, as received, the optic extension tube with the boot connector was detached from the optic connector.The connector housing was opened during the evaluation.There was adhesive trace on the connector housing where the boot connector was attached to the connector housing.The optic fibers in the connector housing were kinked.The catheter failed in-vitro calibration.Light leakage was observed from the kinked locations.The distal and proximal injectate lumens were occluded with blood.The proximal infusion lumen was patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.The customer report of "overheated to the point that it caused damage to the swan-ganz catheter" was not confirmed on evaluation.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, values can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regards to the pressure tubing used with swan ganz catheters, 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.Values should correlate with the patient¿s clinical manifestations.The monitor set-up and calibration for mixed venous oxygen saturation monitoring section of the ifu established: ¿the compatible cardiac output computer can be calibrated prior to catheter insertion by performing an in vitro calibration.When performing an in vitro calibration, do so before preparing the catheter (i.E.Flushing the lumens).The catheter tip must not get wet before an in vitro calibration is performed.An in vivo calibration is required if an in vitro calibration is not done.In vivo calibration may be used to periodically recalibrate the monitor.Refer to the monitor operator¿s manual for detailed calibration instructions.¿ additionally, the precautions section of the ifu states that ¿clinicians using the device should be familiar with the device and understand its applications prior to use.¿ breakage or detachment of an om connector can affect svo2 readings or make them impossible and a new device can be exchanged.In this instance, despite the clinician¿s discovery of damage to the om connector and inaccurate readings with movement of the cable, use of the catheter was continued until it was removed.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

The product lot number was discovered via review of eeprom data.A device history record review was completed and documented that the device met all specifications upon distribution.Udi # (b)(4).

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION 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: 8325994
• MDR Text Key: 136323087
• Report Number: 2015691-2019-00453
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2019

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: 07/01/2019
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 60930870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/20/2019; 03/20/2019; 07/23/2020
• Supplement Dates FDA Received: 02/25/2019; 03/22/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1