MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS DLP PERICARDIAL SUMP; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 12010

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/21/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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.Per the indications for use, this device is intended for use for drainage of the pericardial sac only.Using the device in the manner described in this event may have contributed to this occurrence.

Event Description

Medtronic received information that during an aortic valve procedure, the customer passed this pericardial sump through the aortic valve and the metal spring on the tip of the device became tangled in the chordae tendonae of the mitral valve.The customer worked for approximately 20 minutes to get the device unwrapped from the chordae without success.The device had to be cut into pieces with a wire cutter in order to be removed.After removing and coming off bypass, the echocardiogram showed severe mitral regurgitation.Due to the patient's native mitral leaflets being thick, the customer was unable to repair the valve and subsequently had to replace it.No additional adverse patient effects were reported.

• Brand Name: DLP PERICARDIAL SUMP
• 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 PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6956049
• MDR Text Key: 89561440
• Report Number: 2184009-2017-00038
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 20613994619215
• UDI-Public: 20613994619215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 12010
• Device Catalogue Number: 12010
• Device Lot Number: 2016070751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2016
• 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): Required Intervention