MAUDE Adverse Event Report: PERFUSION SYSTEMS ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 80220

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: visual analysis of the returned cannula shows evidence of damage at the tip.During performance analysis a leak was observed at the damage location.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of an aortic metal tip cannula, it was noted that there was blood leaking from the juncture of the cannula body and metal tip.The customer stated that bleeding was noted when the cannula was turned and snared down.When the cannula was straightened out, the bleeding stopped.The bleeding started again when the cannula was turned.The customer noticed that the tip of the cannula was damaged.The cannula was replaced with a new cannula which was used without issue.No issues had been noted during insertion and priming.No adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the complaint of leaking and damage around the tip of the cannula was confirmed.A sample was taken from a partial lot in inventory and the event was recreated by squeezing the tip area of the device with a hemostat.The investigation concluded that the complaint was not caused by either a manufacturer or supplier issue.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Medtronic will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARTERIAL CANNULA
• 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: 7221161
• MDR Text Key: 98430501
• Report Number: 2184009-2018-00003
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K840002
• 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
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80220
• Device Catalogue Number: 80220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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