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

Model Number 131F7P

Device Problem Deflation Problem (1149)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device involved in this complaint 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.

Event Description

As reported, before use in patient with this swan-ganz catheter, it was not possible to deflate the balloon.The device was replaced by a new unit to solve the problem.There was no allegation of patient injury.Patient demographics were requested but not yet provided.The product is expected to be returned for analysis; however, it has not yet been received.

Manufacturer Narrative

One swan ganz catheter was received by our product evaluation laboratory for a full examination.The report of not possible to deflate the balloon was unable to be confirmed during evaluation.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.The balloon deflated within 1 second without a syringe attached.Maximum deflation time from full capacity is 4 seconds.All through lumens were patent without any leakage or occlusion.The catheter body was free of kinks or indentation.No visible damage was observed on catheter or returned syringe.The instruction for use (ifu) was reviewed and it indicates passively deflate the balloon by removing the syringe and opening the gate valve.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Additionally, patient demographics unable to be obtained.

• Brand Name: SWAN-GANZ CATHETERS
• 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: samantha ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16951865
• MDR Text Key: 315448401
• Report Number: 2015691-2023-13068
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7P
• Device Lot Number: 64776508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• 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