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

Model Number 131F7

Device Problem Deflation Problem (1149)

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

Event Date 07/20/2023

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.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

As reported, while checking before right heart catheterization examination with this swan-ganz catheter, the balloon could not deflate completely.Resolved by replacing with new unit.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (investigation findings, investigation conclusions).Added: d4 (expiration date), h4 (device manufacturer date), h6 (type of investigation).The swan ganz catheter was sent to our product evaluation laboratory for a full evaluation.As received, 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 second.All through lumens were patent without any leakage or occlusion.No visible damage was observed on catheter or returned syringe.Customer report of "balloon could not deflate completely" was unable to be confirmed during evaluation.Further investigation was completed by the engineers in the manufacturing site.The complaint affected unit was returned for evaluation and no defect was found; therefore a product non-conformance or device failure could not be confirmed.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.As part of the manufacturing process, a balloon inspection is performed in all units.A balloon deflation test is performed and balloon free deflation time requirements are established for all models.Additionally, as stated in the instruction for use "passively deflate the balloon by removing the syringe and opening the gate valve".Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.

• 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 eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17593763
• MDR Text Key: 321638659
• Report Number: 2015691-2023-15391
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: 131F7
• Device Lot Number: 64216515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female