MAUDE Adverse Event Report: LIVANOVA USA INC SUCTION WAND, SUCTION SUMP; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-XXXXX
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova usa manufactures the sump cannula.The incident occurred in usa.The involved device has been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa has received a report that, during a procedure, the tip of a sump cannula became entangled in the patient's papillary muscle.Medical team cut the cannula out to remove it from the patient.There was no injury to the patient.
Additional Manufacturer Narrative
During 2022, livanova was informed of other similar events involving a different sump lots.Iin the instruction for use of the suction sump su-20x02, there is the following warning: ¿do not place the suction sump through the leaflets of a valve as damage to the valve may occur¿.Therefore, placing the su-20x02 through the mitral valve is considered an off-label.To prevent reoccurrence, livanova has concluded to enhance the visibility of the above warning by repeating the warning also in a label applied to the peel pouch/primary sterile barrier.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: SUCTION WAND, SUCTION SUMP
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16901973
• Report Number: 1718850-2023-00028
• Device Sequence Number: 5371521
• Product Code: DTS
• UDI-Device Identifier: 00803622105883
• UDI-Public: (01)00803622105883(240)SU-20802(17)230630(10)2016700124
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,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: 06/30/2023
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-20802
• Device Lot Number: 2016700124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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