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

Model Number 774F75

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

Patient demographics unable to be obtained.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.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.B3 (date of event) unknonwn.

Event Description

As reported, in this swan ganz catheter it was found the package was damaged.It seemed to be perforated and thus the sterility of the product was no longer ensured.There was no allegation of patient injury.The device was available for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date) updated section h6 (component code), h6 (device code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion) for the section h6 (investigation findings) the code "malfunction observed without conclusive finding" (imdrf annex c; c24) was chosen.H3: one swan ganz catheter with packaging was received for evaluation.The report of "the package was damaged" was confirmed.Tyvek pouch and tray were received unsealed and perforated at the top of left corner.The product sterility had been compromised.Packaging box and ifu were not returned.No visible damage or abnormality was observed from the catheter.The findings were aligned to a picture provided by the customer.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.Based on further engineering evaluation, the evidence and process explanation support the assertion that the pinholes were not introduced during the primary packaging process.The investigation found no cause for the issue.Additionally, it was concluded that there are manufacturing controls to avoid potential causes related to the reported condition.

• Brand Name: SWAN-GANZ CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18363371
• MDR Text Key: 331108988
• Report Number: 2015691-2023-18576
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Lot Number: 65189205
• 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: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1