MAUDE Adverse Event Report: LIVANOVA USA INC FLEXIBLE AND MALLEABLE SUMP WITH WIRE-WOUND TIP; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-XXXXX
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id, age, gender, weight, ethnicity and race: patient information was not provided.Sorin group (b)(4) manufactures the suction sump.The incident occurred in (b)(6).The involved device has been requested for return to sorin group (b)(4) for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that during heart surgery, the suction sump canulae gripped the valvulae cords.Patient outcome was not provided.
Additional Manufacturer Narrative
Livanova received a report that during heart surgery, the suction sump canulae gripped the valvulae cords.Between march and april 2022, livanova has received three similar complaints (including present report) reporting entanglement of the structures of the mitral valve in the metal tip of the suction sump (item code su-20602).Placing the suction sump su-20602 through the mitral valve is considered an off-label use since within the instruction for use of su-20602 there is the following warning: ¿warning: do not place the suction sump through the leaflets of a valve as damage to the valve may occur¿.Therefore, during the complaint investigations, it was determined that the issue was caused by off-label use.The increase of complaints occurrence is likely due to limited device knowledge by customers: this is supported by the fact that the complaining customers purchased these devices for the first time.There has been no change to the device design, labeling, or manufacturing process, corresponding to the reported complaints and no product nonconformities have been identified.Capa-arv-2022-0006 was issued and it has been determined that with this low level of reportable complaints it is appropriate to make the warning information within the ifu more visible however, the overall risk is at a low level.Since no new warnings were being introduced onto the packaging, that are not already in the ifu, based upon the current risk, no further action needs to be communicated to the field.A new label that contains the same warning currently present in the ifu has been created and will be added to the peel pouch/primary sterile barrier in order to emphasize the warning to the user.The risk is in the acceptable region.Livanova will keep monitoring the market for similar events.
Event or Problem Description
See initial report.

• Brand Name: FLEXIBLE AND MALLEABLE SUMP WITH WIRE-WOUND TIP
• 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: 14084535
• Report Number: 1718850-2022-00029
• Device Sequence Number: 2122014
• Product Code: DTS
• UDI-Device Identifier: 00803622105876
• UDI-Public: (01)00803622105876(240)SU-20602(17)241130(10)2131900126
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-20602
• Device Lot Number: 2131900126
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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