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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR
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MEDTRONIC HEART VALVES DIVISION MEDTRONIC AORTIC PUNCH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Model Number APU448
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 05/26/2017
Event Type  malfunction  
Event Description
The 4.8 teleflex aortic punch was not available.So the surgeon called for and used the medtronic 4.8 aortic punch model ap-448 ref # apu 448 lot # 212796645 and it malfunctioned.When the surgeon attempted to punch the aorta, it failed and got snagged on the tissue and on the second attempt, it was the same result as the first.So switched to the 4.0 teleflex aortic punch.Manufacturer response for medtronic 4.8 aortic punch model ap-448, medtronic 4.8 aortic punch (per site reporter).The operating room will contact medtronic at the request of the surgeon.
 
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Brand Name
MEDTRONIC AORTIC PUNCH
Type of Device
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
710 medtronic parkway
minneapolis MN 55432
MDR Report Key6610455
MDR Text Key76628250
Report Number6610455
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/29/2017,06/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberAPU448
Device Catalogue NumberAPU448
Device Lot Number212796645
Other Device ID NumberMEDTRONIC 4.8 AORTIC PUNCH MO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/29/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/05/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
PROCEDURE OCCURRED IN THE OPERATING ROOM.
Patient Age82 YR
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