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

Model Number	12010
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland drive; brooklyn park MN 55428
• MDR Report Key: 6956049
• Report Number: 2184009-2017-00038
• Device Sequence Number: 16429413
• Product Code: DWF
• UDI-Device Identifier: 20613994619215
• UDI-Public: 20613994619215
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K850385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention