FDA.reportPublic FDA data

MAUDE MDR 9767269

MDR report key
9767269
Report number
2242352-2020-00187
Event key
0
Event type
3
Date of event
2020-02-03
Date received
2020-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
45 BARBOUR POND DRIVE WAYNE NJ 07470 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HST III SEAL (4.5MM)CLAMP, VASCULARMAQUET CARDIOVASCULAR LLCDXCHST III SEAL (4.5MM), 5-PACKHS-304525147699Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2701. R

Event Narratives#

N

Patient 1

TRACKWISE ID# (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NCMR?S FOR THE REPORTED LOT NUMBER. THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

D

Patient 1

THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING HST III SEAL (4.5MM). USE HEARTSTRING ? FOR CENTRAL ANASTOMOSIS OF GRAFT IN CABG OPERATION. DRILL A HOLE WITH AN AORTIC CUTTER AND INSERT A SEAL INTO THE AORTA TO BEGIN CENTRAL ANASTOMOSIS OF THE GRAFT, BUT WITH MORE BLEEDING THAN USUAL. WHEN CHECKING THE INSERTED SEAL, CONFIRM THAT BLOOD HAS LEAKED FROM THE CENTER OF THE SEAL. ALTHOUGH THE ANASTOMOSIS WAS IN PROGRESS, THE SEAL WAS PULLED OUT AND THE ANASTOMOSIS WAS COMPLETED WITHOUT USING ANY SUBSTITUTE.