MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION; SWAN-GANZ CATHETER

Model Number 131F7P

Device Problem Unable to Obtain Readings (1516)

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

Event Type  malfunction  

Event Description

It was reported that during use of a model 131f7p swan-ganz catheter, the physician was unable to get readings from the first swan-ganz, so swapped it for a second swan-ganz but was still not able to get readings.No further attempts to place a swan-ganz were made.An arterial line was placed in order to continue the procedure.There was no patient injury.Patient demographics are not known.The exact date of the event is unknown.The device was saved for return.

Manufacturer Narrative

Our product evaluation lab received one model 131f7 swan-ganz catheter with a monoject limited volume syringe.Visual examination was performed with a 10 to 45x microscope.The report of a catheter issue was unable to be confirmed.All through lumens were tested for patency and leakage as follows: a 10cc syringe was connected to each of the lumens being tested.Each associated port was covered with a fingertip, the entire catheter was immersed in water and pressurized with air by compressing the syringe plunger.The balloon inflated with the returned syringe and was immersed in water to check for leakage.The catheter was submerged in a 37.0 degree celsius water bath and read 37.0 degrees celsius on the vigilance ii monitor.The thermistor temperature reading accuracy was within specification, per the vigilance ii manual.The thermistor circuit was continuous.There were no open or intermittent conditions.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.Cut down was performed on the thermistor connector and there was no visible abnormality.No visible damage was observed from the catheter body or returned syringe.The catheter passed the pressure test with the lab's dpt.A device history record review has been initiated to review the manufacturing records.A supplemental report will be submit with the findings.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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 a part of the monthly review.The udi number for this device is (b)(4).

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.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
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12857506
• MDR Text Key: 284522588
• Report Number: 2015691-2021-06452
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)230626(11)210626(10)63872858,(01)50690103000400(17)230626(11)210626(10)63872858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: 131F7P
• Device Catalogue Number: 131F7P
• Device Lot Number: 63872858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2021
• 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