MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 78320 EOPA 3D 20FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 78320

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

Medtronic received information indicating that during the case, this eopa arterial cannula was used to cannulate a graft.The procedure proceeded normally, but when the surgeon initially attempted to remove the cannula, it would not move.After a short period of manipulation, the cannula was dislodged.Upon examination, the surgeon noted that there was damage to the outer body of the cannula.The surgeon indicated he did not feel the product was at fault and that the cannula had possibly suffered mechanical damage from a clamp.There was a short period of decreased pressure as the cannula was removed, but it quickly resolved and there were no long-term adverse patient effects.Photographs of the product were received, but the product was not returned for analysis.

Manufacturer Narrative

Based on the images provided by the customer and their description of the event, it was confirmed that there was damage to the cannula in the narrower section of the body.The split was in the outer lumen of the device and did not continue through the inner lumen.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 has initiated a formal investigation into recent events involving damage to the outer lumen of eopa arterial cannulae.At this time, there have not been any reports of damage to the inner lumen of any of the cannulae, any leaks, or any adverse patient effects as a result of these issues.(b)(4).

Event Description

Medtronic received information indicating that during the case, this eopa arterial cannula was used to cannulate a graft.The procedure proceeded normally, but when the surgeon initially attempted to remove the cannula, it would not move.After a short period of manipulation, the cannula was dislodged.Upon examination, the surgeon noted that there was damage to the outer body of the cannula.The surgeon indicated he did not feel the product was at fault and that the cannula had possibly suffered mechanical damage from a clamp.There was a short period of decreased pressure as the cannula was removed, but it quickly resolved and there were no long-term adverse patient effects.Product return has been requested, but the cannula has not yet been received.

Manufacturer Narrative

Product return has been requested, but the cannula has not yet been received.Medtronic and the contract manufacturer for this device have initiated an investigation into the event.After completion of the investigation a supplemental report will be filed.(b)(4).

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: CANNULA 78320 EOPA 3D 20FR
• 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: 3914878
• MDR Text Key: 18066448
• Report Number: 2184009-2014-00050
• 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,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2014

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: 07/31/2016
• Device Model Number: 78320
• Device Catalogue Number: 78320
• Device Lot Number: 201309C757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 07/04/2014
• Supplement Dates Manufacturer Received: Not provided; 09/25/2014; 09/25/2014
• Supplement Dates FDA Received: 10/21/2014; 09/14/2017; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2013
• 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