MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AVID THIN-FLEX DUAL STAGE 29/37F VENOUS DRAINAGE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	TF293702A
Medical Device Problem Codes	Incorrect Measurement (1383); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Out of box failures can result from many different product malfunctions, some less serious than others.If the malfunction occurring out of box would have been reportable had it occurred in the patient, then it should be reportable.This should be based on the actual failure mode or non-conformance.In this case the depth markers of the cannula provide a reference for correct positioning of the cannula.If the cannulas were used, potential for serious injury is not remote.The device was not returned for evaluation, as device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Event or Problem Description
It was reported that 18 units of dual-stage venous cannulas markings are off.As reported, it appeared to the surgeon that the markings were slightly off, but the perfusionist did not see any differences.The case proceeded in normal fashion.
Event or Problem Description
Per imaging evaluation report of tf293702a dual-stage venous cannula's markings are off was unable to be confirmed.Two images were provided.First image showed a cannula from reported model on top of the tyvek lid from reported model and lot number.Second image showed two cannulas inside the pouch.Location of depth markers was not able to be confirmed.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (type of investigation, investigation findings, investigation conclusions).Per image evaluation, no identifiable non-conformances were observed.The reported complaint is not confirmed, and an edwards defect is not confirmed.No injury was indicated as a result of this event.Attempts have been made to obtain product for evaluation.No device was returned.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.H11: corrected data: corrected section h6 (device code).

• Brand Name: AVID THIN-FLEX DUAL STAGE 29/37F VENOUS DRAINAGE CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16294531
• Report Number: 2015691-2023-10558
• Device Sequence Number: 17710379
• Product Code: DWF
• UDI-Device Identifier: 50690103161873
• UDI-Public: (01)50690103161873(17)250816(11)220817(10)359262
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2025
• Device Model Number: TF293702A
• Device Lot Number: 359262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 08/11/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 08/09/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown