MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS DLP AORTIC ROOT ANTEGRADE CANNULA W/VENT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 24009

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: visual inspection of the returned device confirmed a small piece of excess material extending from the tip of the cannula.Conclusion: medtronic is unable to determine the root cause of this issue at the current time as the investigation is still in progress.A supplemental report will be filed upon completion of the investigation.

Event Description

Medtronic received information that during preparation for a case, the customer observed the tip of this cannula was different from what they were accustomed to.The product was not used and was replaced with another.There was no patient involvement in this product issue.

Manufacturer Narrative

Conclusion: after investigation at medtronic and its supplier, the excess material was confirmed to be comprised of the same material as the tip of the cannula.Upon magnified inspection, striations were present on the inside of the tip, suggesting that the excess material may have been present due to inserting the needle into the tip several times.It was also noted that the excess piece appeared to be firmly attached to the tip.In manufacturing this product, several inspections are in place during the assembly process to identify this type of abnormality.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Medtronic will continue to monitor for future occurrences and trends.

• Brand Name: DLP AORTIC ROOT ANTEGRADE CANNULA W/VENT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6079826
• MDR Text Key: 59230023
• Report Number: 2184009-2016-00023
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K831591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

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 Expiration Date: 03/31/2019
• Device Model Number: 24009
• Device Catalogue Number: 24009
• Device Lot Number: 2016031521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• 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