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

Model Number	5140-4629
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Death (1802); Perforation (2001)
Date of Event	10/08/2018
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC; 620 alpha drive; pittsburgh PA 15238
• MDR Report Key: 8033968
• Report Number: 2531527-2018-00009
• Device Sequence Number: 1499331
• Product Code: DWF
• UDI-Device Identifier: 00814112020166
• UDI-Public: (01)00814112020166(17)210227(11)180227(10)198949
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death