MAUDE Adverse Event Report: MEDTRONIC DLP AORTIC ROOT CANNULAE

Catalog Number 10012

Device Problems Break (1069); Crack (1135)

Patient Problem Great Vessel Perforation (2152)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

Medtronic dlp ref 10012, 12 ga otherwise known as cold needle, lot #2014031020 was used in this case, aortic valve replacement/coronary artery bypass grafting (avr/cabg).The hub of the needle couldn't be released from the obturator, instead it created a crack and broke below the level of the hub creating a hole in the aorta.Note: in reading the op report, no mention was made of any ill effects to the patient during or after the surgery.The item was sequestered and given to risk.The remaining cold needles with the same lot number were pulled and given to supply chain.

• Brand Name: DLP AORTIC ROOT CANNULAE
• Type of Device: AORTIC ROOT CANNULA
• Manufacturer (Section D): MEDTRONIC; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 4154853
• MDR Text Key: 15343974
• Report Number: 4154853
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/24/2014

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 Catalogue Number: 10012
• Device Lot Number: 2014031020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2014
• Patient Sequence Number: 1
• Patient Age: 81 YR