MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR

Model Number	ICF100
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: if the catheter becomes occluded during use, it may require a catheter exchange or a change of operative strategy.The subject device was not returned for evaluation as it was discarded.The reported event cannot be confirmed with the available information.The root cause of this event cannot be conclusively determined.However, the event was likely due to procedural/technique related factors.Per the instructions for use (ifu), "care should be used when handling the devices.Damage may result from kinking or stretching the devices.Do not use the device if kinked." edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.If new information becomes available, a supplemental report will be submitted.
Event or Problem Description
Edwards received notification that this intraclude device model ifc100 was damaged during use.The procedure was a mitral valve repair with intraclude clamping.The intraclude was positioned in the ascending aorta with some difficulties in identifying the position of the tip of the device and additional placement maneuvers.The aortic clamping and cardioplegia delivery sequence was initiated.Aortic occlusion was visually confirmed on tee, but aortic root pressure did not drop after occlusion and cardioplegia did not completely stop the heart, showing high pressures and low flows.After a second attempt of cardioplegia delivery, the use of intraclude device was aborted, and the procedure continued with the use of an external clamp (chitwood clamp).As reported, the catheter was kinked/twisted while being placed in the aorta.Repair was successful and the mitral valve showed just a trivial regurgitation.The patient did not suffer any injury due to the aborted attempt to clamp the aorta with the intraclude device.Reportedly, the cannula and its packaging were inspected prior use following the instructions for use (ifu) and no issues were observed by the medical team neither on the device packaging nor in the device itself.The patient was noted as to have done very well and was discharged home.After discussion, the surgeons agreed that the root cause could have been a bad positioning and twist of the device.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections d4 (expiration date), h4, h6 (type of investigation, investigation conclusions).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.H11: corrected data: corrected section h6 (component codes, health effect - impact code).

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11672153
• Report Number: 2015691-2021-02464
• Device Sequence Number: 11538232
• Product Code: DXC
• UDI-Device Identifier: 00690103190007
• UDI-Public: 00690103190007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: ICF100
• Device Lot Number: 63429969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 14 YR