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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. LIVANOVA CARDIOPLEGIA CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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SORIN GROUP USA, INC. LIVANOVA CARDIOPLEGIA CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number AR-11014
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2016
Event Type  malfunction  
Event Description
The tip of the aortic root cannula is bending under the pressure of the aorta during the valve procedure.Surgeon had difficulty giving cardioplegia and venting the aorta.[the 1cm long tip is tapered so that it can dilate a hole made by a needle.At 1cm there is a flange to prevent cannula from going in further.7mm from the tip (and 3mm from the flange) are two small holes that assist with the air venting at the end of the case.The tip is bending over at the location of the two holes.].
 
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Brand Name
LIVANOVA CARDIOPLEGIA CANNULAE
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP USA, INC.
14401 w. 65th way
arvada CO 80004
MDR Report Key5856345
MDR Text Key51496737
Report Number5856345
Device Sequence Number1
Product Code DWF
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 07/06/2016
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 Expiration Date04/30/2019
Device Catalogue NumberAR-11014
Device Lot Number1611700013
Other Device ID Number00803622103018
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/06/2016
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer07/06/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTHER, PATIENT WAS ON CARDIOPULMONARY BYPASS
Patient Age69 YR
Patient Weight108
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