MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE; CATHETER, FLOW DIRECTED

Model Number TS105F5

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

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

Event Date 09/16/2021

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.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that although arterial blood pressure was observed for a brief second, it gradually moved down and eventually became unable to be observed on the first day of use.The catheter and the pressure monitoring set were replaced, and the problem was solved.Both devices were used with the same patient.There was no abnormal waveform observed.The dpt was zeroed before use.The data logs were not provided.There was no occlusion, leakage or kink noted.The patient was not treated based on the incorrect value.The patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One ts105f5 catheter with bd 1 cc syringe was received for evaluation.The reported pressure measurement issue was not able to be confirmed from the evaluation.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from catheter body, balloon and returned syringe.The balloon inflated clear, concentric and remained inflated for more than five minutes without leakage.This sample was then transferred to the irvine lab for further evaluation.The catheter passed the pressure test with the returned dpt.The pressure reading was stable during the 8 hour long output drift test.Per edwards pressure monitoring ifu, "poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively complaint pressure tubing, small bore tubing, loose connections, or leaks." the reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.Although no fault was found, an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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 part of this monthly review.

• Brand Name: SWAN-GANZ TRUE SIZE
• Type of Device: CATHETER, FLOW DIRECTED
• 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: 12685852
• MDR Text Key: 278382793
• Report Number: 2015691-2021-05892
• Device Sequence Number: 1
• Product Code: DYG
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 63720347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2021
• 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