MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA 3D VENTED ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 78222

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Medtronic received information indicating that during the case, using this eopa 3d arterial cannula, the customer noticed that the suture ring was loose.The customer re-positioned the suture ring and the device was used with no adverse patient effects.

Manufacturer Narrative

Medtronic could not confirm the product event because the product that is the subject of this product event was discarded by the customer.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.However, the customer did provide two un-opened devices from the same lot number as the device that is the subject of this product event.The product analysis and investigation of these two devices is still ongoing.When the product analyses and investigations are completed a supplemental report will be provided.

Manufacturer Narrative

Analysis: upon receipt at medtronic's quality laboratory, visual inspection of the two returned cannula, from the same lot as the complaint device, showed the suture collars were within specification and found the suture collars to snugly fit their respective cannula.Additionally, three other samples from a different lot were evaluated, and again the suture collars were within specification and snugly fit the cannula.Conclusion: the complaint could not be confirmed because the complaint device was not returned for evaluation, and the evaluation of other samples showed that the samples conformed to specifications.The device history record was reviewed and revealed that a new operator was performing the inspection of this device.Therefore, if an incorrect suture collar was used, it may have not been detected during inspection.Medtronic¿s sub-manufacturer has been made aware of the issue of incorrect suture collar size and has heightened awareness of the issue.Additionally, a corrective action was initiated to address this kind of occurrence, but the product that is the subject of this report was built prior to the initiation of the corrective action.Medtronic will continue to monitor for future events.

Manufacturer Narrative

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

• Brand Name: EOPA 3D VENTED 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): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3887008
• MDR Text Key: 4678243
• Report Number: 2184009-2014-00045
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2014

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: 04/30/2017
• Device Model Number: 78222
• Device Catalogue Number: 78222
• Device Lot Number: 2014041647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 06/20/2014
• Supplement Dates Manufacturer Received: Not provided; 06/20/2014
• Supplement Dates FDA Received: 07/17/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1