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

Model Number 20014

Device Problem Device Handling Problem (3265)

Patient Problem Aortic Dissection (2491)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Medtronic's investigation is in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that as the customer was cutting the suture to remove this aortic root vent cannula, the suture would not cut as expected.The customer applied more pressure than normal against the blue flange tip on the cannula in an attempt to cut the suture and noted the suture lodged in a small gap between the cannula body and the blue flange.The customer then cut the suture to release the device from the vessel.Once removed, a small tear was noticed in the aorta that the customer suggested was likely due to the excessive force against the device during the attempt to cut the suture.The tear was repaired.There was no further injury to the patient.The product is expected to return to medtronic for analysis.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality assurance laboratory, visual inspection identified a space between the cannula body and the blue flange tip.Medtronic's investigation is in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality assurance laboratory, visual inspection identified a 0.016 inch gap between the cannula body and the blue flange tip.Medtronic's investigation is in progress.

Manufacturer Narrative

Conclusion: analysis confirmed the gap between the cannula body and blue flange.No similar occurrences have been identified at this time.Medtronic will continue to monitor for similar occurrences.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH VENT LINE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6250719
• MDR Text Key: 64881777
• Report Number: 2184009-2017-00007
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 20613994495543
• UDI-Public: 20613994495543
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2017

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: 09/30/2019
• Device Model Number: 20014
• Device Catalogue Number: 20014
• Device Lot Number: 2016090203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 02/23/2017
• Supplement Dates FDA Received: 02/01/2017; 02/01/2017; 03/16/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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
• Patient Outcome(s): Required Intervention