MAUDE Adverse Event Report: LIVANOVA USA PERICARDIAL SUMP 1/4 CONN; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-20602
Medical Device Problem Codes	Crack (1135); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the suction wand.The incident occurred in usa.Livanova is following up with the information that patient reported minor/temporary injury.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 inca has received a report that, during the procedure, the tip of sump got tangled in the mitral valve chordae.This caused a 20 minute delay in the procedure while the surgeon needed to use wire cutters to get it out of the valve.There was no harm to the patient's valve.According to submitted, patient reported minor/temporary injury.
Additional Manufacturer Narrative
H10: through follow-up communication with the customer, livanova learned that there was no cannula disconnection or break.The surgeon did place the cannula into the patient¿s valve and needed to de-tangle it from the chordae.The valve wasn¿t damaged and the patient is unharmed.However, this caused a 20-30 minutes of delay on bypass procedure.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: placing this involved suction sump type (catalogue: su-20602) through the mitral valve is considered an off-label use since within the device instructions for use there is the a warning to not place the suction sump through the leaflets of a valve as damage to the valve may occur.A capa was issued and a new label that contains the same warning present in the device instructions for use was created and was added to the peel pouch/primary sterile barrier in order to emphasize the warning to the user.For the reported complaint, it was confirmed that the warning label was present in the primary package.Therefore, based on the above, root cause of the reported event was traced back to the user, who used the product against the instructions for use, as off-label use.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
**udi related data quality updates only**.D2.Correct common device name updated in the dedicated section d2a.G4.Pma/510(k) number added in the dedicated section.

• Brand Name: PERICARDIAL SUMP 1/4 CONN
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 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: 18371858
• Report Number: 1718850-2023-00039
• Device Sequence Number: 18037228
• Product Code: DTS
• UDI-Device Identifier: 00803622105876
• UDI-Public: (01)00803622105876(17)260918(10)2326200066(11)231013(240)SU-20602
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K982891
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/02/2024

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: 09/18/2026
• Device Model Number: SU-20602
• Device Lot Number: 2326200066
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 01/22/2024; 08/02/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/19/2024; 02/19/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2023
• 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