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

Model Number 69328

Device Problem Split (2537)

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

Event Date 07/29/2014

Event Type  malfunction  

Event Description

Medtronic received information that while weaning from bypass, the surgeon observed a tear in the body of this venous cannula.The point where the damage occurred had been bound by thread, but there had been no clamps placed at the site.The customer elected to cover the damaged area of the cannula and weaning was successfully completed with no adverse patient effects.The customer was unable to determine the exact lot number of the cannula due to the fact that two of the same cannulae from different lots were used in the same case.The possible lot numbers are 2014021807 and 2014021178.

Manufacturer Narrative

Product analysis: visual inspection showed a split in the device and under magnification there appeared to be bubbles in the cannula body.Conclusion: visual analysis confirmed the tear/split in the cannula device.Additional investigation in ongoing at the medtronic core technologies group to understand what may have caused this occurrence.There were no abnormalities noted in the device history record review.There have been no additional confirmed occurrences similar to this for this product line (complaint review from (b)(4) 2013 to (b)(4) 2014).The investigation is ongoing.(b)(4).

Manufacturer Narrative

Additional investigation of this product event has been completed.The wall thickness of the device was measured and found to be within specification.The cause of the product event is unknown, but a contributory cause may have been repeated or extreme flexing at this part of the cannula.

• Brand Name: DLP SINGLE STAGE VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC 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: 4041926
• MDR Text Key: 4909688
• Report Number: 2184009-2014-00067
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K842375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 69328
• Device Catalogue Number: 69328
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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