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

Model Number 5140-4629

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Perforation (2001)

Event Date 10/08/2018

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.The involved device was not made available for return for further investigation.Based on the event description, there is no suspicion of a device malfunction.The patient death was a result of the physician's attempt to re-position the cannula without support.The device instructions for use (ifu) contain a clear warning against re-positioning, which states "do not attempt to position or reposition the cannula without the introducer in place.Damage to the cannula and/or injury to the patient may result." this event was the result of the user failing to adhere to the instructions outlined in the ifu.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

After inserting the protek duo veno-venous cannula and positioning the tip through the pulmonic valve into the pulmonary artery, the device slipped back and the physician decided to re-position.The cannula was pushed forward and perforated the pulmonary artery.A surgeon was called and was in the room within 3 minutes and was unable to contain the perforation.The patient expired.

• Brand Name: PROTEKDUO 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: greg johnson ; 620 alpha drive; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 8033968
• MDR Text Key: 125981560
• Report Number: 2531527-2018-00009
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00814112020166
• UDI-Public: (01)00814112020166(17)210227(11)180227(10)198949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2018

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 Expiration Date: 02/27/2021
• Device Model Number: 5140-4629
• Device Catalogue Number: 5140-4629
• Device Lot Number: 198949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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): Death