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

Catalog Number 5140-4629

Device Problems Break (1069); Crack (1135)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Livanova received a report that blood was noticed oozing from the distal outflow near the coil/bifurcation of a protekduo cannula after the patient was placed in a physical therapy chair.The protekduo was removed and replaced without incident with a different vendor's cannula accessing through the femoral vein.No patient harm was reported.

Manufacturer Narrative

Patient information was not provided.Lot number was not provided.The udi and expiration date could not be determined.Device manufacture date: lot number was not provided, so the manufacture date is unknown.Livanova manufactures the protekduo cannula.The event occurred in (b)(6).There was no report of patient injury.Through follow-up communication, livanova learned that the patient had been on support with the protekduo for 65 days when the event occurred.The patient was re-cannulated via the femoral vein using a competitor product without issue and the protekduo cannula was removed.The exact lot number of the 29 fr protekduo cannula was not provided.Based on a review of the sales records for the complaint site, the cannula was most likely from lot 281377, 288565, or 304658.No deviations or non-conformities relevant to the reported issue were identified for any of these lots, and no similar complaints have been recorded for these lots.The complained unit was made available for further evaluation at manufacturer site.The visual inspection performed confirmed the presence of a break in the bond joint between the y connector and the distal cannula.The crack was confirmed to extend into the blood pathway, causing the leak reported by the site.As per the protekduo directions for use (dfu), the tandemheart system has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.E., longer than 30 days) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ecmo).Based on this, and considering that the issue occurred after more than 30 days of support, a product malfunction can be excluded and the most likely root cause of the reported event was a mechanical stress due to use conditions which exceeds the recommended duration of support.A capa (capa-(b)(4)) has been initiated to address this type of crack.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: 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: 15748915
• MDR Text Key: 307008531
• Report Number: 2531527-2022-00048
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 5140-4629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female