MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES VENT CATHETER; CHAMBER-DECOMPRESSION CARDIAC CATHETER

Model Number	E063
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Edwards received notification that a hair was noticed on the tip of this vent catheter.
Additional Manufacturer Narrative
If the particulate material is metal or glass or it is found in the fluid path of a canula with an intra-arterial indication and a surface area of 0.8 mm2 or maximal diameter of 1.725mm.If the device is used in the patient, the contamination could potentially enter the bloodstream and embolize and therefore the potential for injury is not remote.The device was not returned for evaluation, as the device availability is unknown.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
Additional Manufacturer Narrative
If the particulate material is metal or glass or it is found in the fluid path of a canula with an intra-arterial indication and a surface area of 0.8 mm2 or maximal diameter of 1.725mm.If the device is used in the patient, the contamination could potentially enter the bloodstream and embolize and therefore the potential for injury is not remote.The device was not returned for evaluation, as the device availability is unknown.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
Edwards received notification that a hair was noticed on the tip of this vent catheter.
Additional Manufacturer Narrative
H10: additional narratives: updated d4, h4, and h6 per new information received.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: EDWARDS LIFESCIENCES VENT CATHETER
• Common Device Name: CHAMBER-DECOMPRESSION CARDIAC CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; one edwards way; mailstop anton 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13195439
• Report Number: 2015691-2022-03280
• Device Sequence Number: 17240875
• Product Code: DWF
• UDI-Device Identifier: 50690103030902
• UDI-Public: (01)50690103030902(17)230416(10)63104554
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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: 04/16/2023
• Device Model Number: E063
• Device Lot Number: 63104554
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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
• Patient Sex: Unknown