FDA.reportPublic FDA data

MAUDE MDR 9888004

MDR report key
9888004
Report number
2242352-2020-00315
Event key
0
Event type
3
Date of event
2020-03-06
Date received
2020-03-27
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
1HSK III SYSTEM (3.8MM)CLAMP, VASCULARMAQUET CARDIOVASCULAR LLCDXCHST III SYSTEM (3.8MM)HSK-303825149291N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

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 BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

D

Patient 1

THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING HST III SYSTEM (3.8MM) , THEY STATED THAT SEAL IS CAUGHT IN THE MIDDLE PART OF DELIVERY DEVICE IN THE PROCESS OF SEPARATING AFTER CHECKING IN SEAL LOADER WINDOW THAT SEAL IS PROPERLY INSTALLED IN TUBE AT DELIVERY DEVICE. I TRIED TO REMOVE THE SEAL FORCIBLY BUT I COULDN'T USE IT BECAUSE THE SEAL DIDN'T COME OFF. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.