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

Model Number 77620

Device Problems Crack (1135); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

Medtronic received information indicating that during the case, the outer lumen of this 77620 cannula cracked where it was sutured to the patient's skin.There were no leaks reported, and the device was used to complete the case.There were no adverse patient effects as a result of the issue.The customer indicated that the product would not be returned for analysis, but a photograph of the cannula was provided.

Manufacturer Narrative

The product was not available to medtronic for analysis, but the reported damage to the cannula was confirmed through a photograph provided by the customer.Based on the photograph and the statement from the customer, the split was in the outer lumen but did not affect the integrity of the inner lumen, and no leaks were observed.The photograph of the cannula was forwarded to the contract manufacturer for additional analysis and investigation of root cause.(b)(4).

Manufacturer Narrative

The lot number of the cannula was not provided by the user facility, so a device history review could not be performed.Medtronic has initiated a formal investigation into the root cause of this event.

Event Description

Medtronic received information indicating that during the case, this 77620 cannula cracked where it was sutured to the patient's skin.The device was used to complete the case.No adverse patient effects were reported.The product will not be returned, reason not given.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: EOPA 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: 3870949
• MDR Text Key: 4569742
• Report Number: 2184009-2014-00041
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/18/2014

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 Model Number: 77620
• Device Catalogue Number: 77620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: Not provided; 06/18/2014; 06/18/2014
• Supplement Dates FDA Received: 07/11/2014; 09/14/2017; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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