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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the protekduo cannula.The incident occurred in (b)(6).A medical assessment of similar events reporting svc syndrome was conducted.The result of the assessment is that the syndrome can be solved only by additional medical intervention or by removal of the obstruction.The reported syndrome is not related to any specific product malfunction and is related to the use of cannula.In addition, this type of event depends on cannula size selected for patient vessel conformation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through literature review livanova became aware of 3 patients supported with the protekduo cannula which developed svc (superior vena cava) syndrome.

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the protekduo cannula.The incident occurred in (b)(6).A medical assessment of similar events reporting svc syndrome was conducted.The result of the assessment is that the syndrome can be solved only by additional medical intervention or by removal of the obstruction.The reported syndrome is not related to any specific product malfunction and is related to the use of cannula.In addition, this type of event depends on cannula size selected for patient vessel conformation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Through literature review livanova became aware of 3 patients supported with the protekduo cannula which developed svc (superior vena cava) syndrome.

• 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: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13590621
• MDR Text Key: 286048840
• Report Number: 2531527-2022-00017
• 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: Literature
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/23/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other