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

Model Number 777F8

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One 777f8 catheter with attached monoject 1.5 cc limited volume syringe, 3 three way stopcocks, and non-ew 8fr introducer which located on catheter body between 85.5 cm and 98 cm proximal from catheter tip was returned for examination.The customer's report of the cco measurement issue was not able to be confirmed during evaluation.However, damage of thermal filament cover was confirmed.There was no fault messages showed on the 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 catheter ran cco in 37.0 c water connected to a vigilance ii monitor for five minutes without any errors.The thermistor and thermal filament circuits were continuous; there were no open or intermittent conditions.There was no visible inconsistence observed on the eeprom data.The resistance value of the thermal filament circuit was measured 38.04 ohms, which was in specification.Both the thermistor and thermal filament connectors were opened and found no visible inconsistencies.The catheter body was wavy between 47 cm and 66 cm from catheter tip.Two kinks were observed on catheter body at 61 cm and 98 cm from catheter tip.The location of the kink at 98 cm aligned to the location of the non-ew introducer adapter.The proximal and distal heater bonding were torn and blood was observed in heater shrink wrapping.The torn edges at the proximal side appeared to match up, however, the torn edges at distal side were not able to match up.The catheter was able to pass through the returned 8 fr introducer and the lab 9 fr introflex introducer without any restriction.The was no other visible damage or inconsistency observed from the catheter body, the balloon or returned syringe.All through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.A review of the manufacturing records indicated that the product met specifications upon release.As part of the manufacturing process, 100% balloon inflation and visual inspection is performed.A product risk assessment was initiated to address the failure.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.

Event Description

It was reported that the continuous cardiac output (cco) became unmeasurable during a procedure.The swan-ganz cco catheter was used with a vigilance ii monitor.The operators examined and verified that there was no abnormality in the cable used.After replacing the monitor, the cco was measured not continuously but intermittently.On the following day, the monitors were examined and confirmed to be normal.The operators requested an investigation on the suspect catheter.There was no injury or complications.During the product evaluation, it was revealed that the distal and proximal heater bonding were torn, and a part of shrink wrapping was missing.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12824384
• MDR Text Key: 282568186
• Report Number: 2015691-2021-06330
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2021

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: 10/12/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63411144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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