MAUDE Adverse Event Report: LIVANOVA USA INC. RAP FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	23/25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova initiated an 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 inc.Received a report of a rap femoral venous cannula which broke during usage.The event occurred during procedure.There was no patient impact.
Additional Manufacturer Narrative
H11: the analysis conducted by device external supplier on the pictures provided by the customer concluded that the device broke during the unit removal process after its use in the procedure, thus the cannula did not present any functional issue during the whole surgery.In addition, no signs of delamination or under cured parts was evident in the images received, and consequently excluding any cannula curing failure.Two samples of body subcomponent batches used in the manufacturing process of the claimed cannula lot were visually inspected, and no deviation was found out.Furthermore, no non-conformity was identified in the last two years involving this cannula reference.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
H11: complained cannula returned for investigation at manufacturer site: the fracture of the body was confirmed at the wire-reinforced area and was following a spiral pathway.By bending the cannula in other locations, it fractured in the same modality of the initial break.Complaints database review did not identify any other similar case for this cannula lot, out of 300 manufactured units, nor a concerning trend has been detected.Based on investigation findings, a manufacturing issue was ruled out.From the physical investigation of the part, however, it was confirmed that the cannula fractured easily when bent, therefore an isolated product failure was confirmed.This was likely favored by an isolated transport or storage deviation which weakened the cannula after release, allowing its use during procedure but eventually causing a fracture when handled during removal.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: RAP FEMORAL VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, 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: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23556328
• Report Number: 1718850-2025-90008
• Device Sequence Number: 13226234
• Product Code: DWF
• UDI-Device Identifier: 00803622125805
• UDI-Public: (01)00803622125805(240)200-150(17)280421(10)2511200060
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K052081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

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 Model Number: 23/25
• Device Catalogue Number: 200-150
• Device Lot Number: 2511200060
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 03/13/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/18/2025; 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown