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

Model Number 78320

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problem Stroke/CVA (1770)

Event Date 03/26/2015

Event Type  Injury  

Event Description

Medtronic received information indicating that following the case using this eopa 3d cannula, as the cannula was removed from the patient, the physician noticed the suture ring was missing.The physician indicated that during the case there was limited visibility due to there being a lot of blood around the arteriotomy site.Due to the limited visibility the physician pushed the cannula further into the aorta, which may have caused the ring to go into the aorta.The ring could not be located with x-ray or head ct.The patient experienced a mild stroke, but it could not be determined if it was related to the missing suture ring.Product return is not expected.

Manufacturer Narrative

The device was discarded by the customer and will not be returned to medtronic for analysis.Medtronic's quality engineers have initiated an investigation into this product event.Upon completion of the investigation a supplemental report will be filed.(b)(4).

Manufacturer Narrative

Medtronic cannot confirm or deny this complaint as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.The device history record was not reviewed as no lot number was provided.If the product is returned, this pe will be reopened and the analysis will and investigation will be updated.A review of complaints received from march 2013 thru may 2015 for this part number and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences.

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): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; 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: 4714610
• MDR Text Key: 5583727
• Report Number: 2184009-2015-00013
• 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: 06/19/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 78320
• Device Catalogue Number: 78320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided; 06/19/2015; 06/19/2015
• Supplement Dates FDA Received: 07/14/2015; 09/18/2017; 09/18/2017
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 00087 YR