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

Model Number E063

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

Edwards received notification that a hair was noticed on the tip of this vent catheter.

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.

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 Description

Edwards received notification that a hair was noticed on the tip of this vent catheter.

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
• Type of Device: 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
• MDR Text Key: 285745125
• Report Number: 2015691-2022-03280
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 50690103030902
• UDI-Public: (01)50690103030902(17)230416(10)63104554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• 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