MAUDE Adverse Event Report: CARDIAC ASSIST INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	5140-5131
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.No patient information has been provided.D.4.Udi and expiry date are pending.H.4.Manufacturing date is pending.H.11.Livanova manufactures the protek duo veno-venous cannula.According to customers, no clotting was visible in the cannula.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 received a report that, at the unclamping of the 31 fr protek duo cannula to start flowing, the cannula was sluggish.The flow was never more than 1.5 l/min.Medical team elected to change out the cannula witht a new 31 fr protek duo cannula.The new cannula worked correctly.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The present follow up is to ament the intial report submitted on 11/feb/2025 with the incorrect manufacturer name.The correct manufacturer information have been updated in fields d3, g1 and g2 and are also reported below: cardiacassist inc.Customerquality@livanova.Com.620 alpha drive, pittsburgh, pennsylvania 15238 united states.
Additional Manufacturer Narrative
Protekduo 31 fr unit was returned for investigation.Visual inspection confirmed the presence of kinking/buckling at the base of the y-connector, which most likely contributed to the reported issue.The kink occurred outside of the insertion site, external to the patient.It appears that the cannula was kinked as a result of bending the assembly or forces at that location that caused an acute bend.This can happen when the customer affixes the cannula and sets the pump and lines as they can put pressure on the cannula.This would not be possible ¿as packaged¿ because of the lack of space in the pouch and so had to happen once removed form the package.With the introducer in the product, kinking of the inner cannula would not have been probable due to the full inner support.It can be concluded that the kink occurred after the placement, once the introducer was removed, most likely as a result of the line management at the connector end and/or securement to the patient with pressure from sutures.From the review of the livanova complaint database, no further similar complaint was reported for this lot, nor a concerning trend has been identified.As per protekduo dfu, following warnings are reported: "avoid kinking the protekduo cannula during handling and preparation.Note: the basket area around the proximal holes is more susceptible to kinking than other areas." and "avoid kinking the protekduo cannula or introducer during insertion and placement within the patient¿s vasculature.Note: the area of the cannula that tapers from large to small diameter (transition region) is more susceptible to kinking than other areas.Avoid positioning this region with a tight bend radius during support." in conclusion, it cannot be ruled out that the method of cannula securement and line management at the connector end caused stress at the bond-joint resulting in kinking, which most likely contributed to the reported low flow.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.
Additional Manufacturer Narrative
D3: updated manufacturer information.D4: updated product catalog number and udi.G1: updated g1 contact office - manufacturing site to cardiac assist inc.[2531527].
Event or Problem Description
See initial report.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC ASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIAC ASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; 80004, CO 15238
• MDR Report Key: 21353088
• Report Number: 1718850-2025-00002
• Device Sequence Number: 18393125
• Product Code: DWF
• UDI-Device Identifier: 00814112020319
• UDI-Public: (01)00814112020319(17)270815(11)240815(10)435393
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160257
• 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): 04/22/2026

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 Catalogue Number: 5140-5131
• Device Lot Number: 435393
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/11/2025; 04/17/2025; 01/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/11/2025; 05/15/2025; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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