MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS DLP MALLEABLE SINGLE STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 68116

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: visual inspection confirmed the wire protruding from the device.Detailed analysis is in progress the conclusion is not yet available as the investigation is still in progress.(b)(4).

Event Description

Medtronic received information indicating that at the end of a liver transplant after removing this cannula from the superior superficial femoral vein, the customer reported the malleable wire was protruding out of the cannula body.There were no adverse patient effects as a result of this issue.

Manufacturer Narrative

Conclusion: after investigation at medtronic and its supplier, the complaint of a protruded malleable wire was confirmed.Review of the complaint device at medtronic and (b)(4) revealed that the malleable wire appeared to be straightened and pulled down the cannula body, resulting in the misplacement of the wire.Medtronic and its supplier attempted to duplicate this occurrence and were unable to do so.This is considered highly unusual damage to occur while using this device.The device history record was reviewed and no abnormalities were documented during the manufacture of this product.A sampling of each lot is subjected to a bend test at the tip of the device; no failures were identified.It is unknown where the issue occurred or what may have caused this occurrence.A review of complaints received for this part number showed no trends for this occurrence or similar confirmed occurrences warranting escalation.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.The reported information indicates the cannula was placed in the superficial superior femoral vein, which is not listed as the intended placement in the product's indications for use (ifu).(b)(4).

• Brand Name: DLP MALLEABLE SINGLE STAGE VENOUS CANNULA
• 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: 5469434
• MDR Text Key: 39636326
• Report Number: 2184009-2016-00003
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

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: 05/31/2018
• Device Model Number: 68116
• Device Catalogue Number: 68116
• Device Lot Number: 2015050574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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