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

Model Number	5140-4629
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1., a5., a6.Patient identifier, race and ethnicity were not provided.H10.Livanova manufactures the protekduo 29fr.The reported event occurred in (b)(6).Through follow-up communication with the livanova representative and the customer, it was discovered that the device was discarded by the user and was not available for return.The customer indicated that they chose the protekduo due to respiratory distress and that the patient had no cardiac issues.The customer confirmed that the 29fr protekduo which extracted tissue was the second cannula attempted.After the first larger-sized cannula (31fr) they attempted to insert kinked, the 29fr protekduo was attempted which also experienced difficulty, was removed right away and ultimately was not used.Upon removal of this second 29fr cannula, vascular damage was noted.The customer reported that they switched to a 17fr femoral livanova cannula and single ij insertion and no further issues were noted.As the device was discarded, nothing was available for return to livanova for evaluation.However, photographs were provided and a visual inspection was performed, which confirmed the reported issue.There was no visible damage to the cannula in the photos, however tissue was identified around the cannula.The dhr was reviewed and no non-conformities, abnormalities, or deviations relevant to the reported issue were observed.All tests were completed with passing results and all measurements were within designated specifications.A complaint history review was conducted and a few other reports of vascular damage were identified.However, all other reported events were identified as part of literature reviews and the full details of the event including exact nature of the vascular damage is not known in those cases.At this time, there is no other known instance of this type of tissue damage occurring.Based on all available facts and given the alleged difficulty inserting both the 31fr and 29fr cannula and the ultimate success of the 17fr cannula, the most likely root cause of the reported failure mode and patient injury is the use of an oversized cannula for the patient and excessive force during insertion by the surgeon.The repeated downsizing reported by the customer in order to achieve a successful insertion suggests that the cannula was oversized at the baseline.At this time, no specific corrective action is deemed necessary for this issue.If any additional information pertinent to the reported event is received, it will be provide in a supplemental report.
Event or Problem Description
Livanova received a report that the customer experienced difficulty inserting a protekduo 29fr cannula via the right internal jugular vein.This occurred after the customer already had experienced difficult insertion of a 31fr protekduo.The 29fr cannulae was removed and the physician noted that tissue was extracted with the cannula upon removal.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 19498406
• Report Number: 2531527-2024-00003
• Device Sequence Number: 6812556
• Product Code: DWF
• UDI-Device Identifier: 00814112020166
• UDI-Public: (01)00814112020166(17)250624(11)220624(10)350639
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2025
• Device Model Number: 5140-4629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 40 KG