FDA.reportPublic FDA data

MAUDE MDR 9837080

MDR report key
9837080
Report number
2242352-2020-00239
Event key
0
Event type
3
Date of event
2020-02-19
Date received
2020-03-16
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 SEAL (4.5MM)CLAMP, VASCULARMAQUET CARDIOVASCULAR LLCDXCHST III SEAL (4.5MM), 5-PACKHS-304525146430Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-160

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 SEAL (4.5MM) . AFTER PERFORMING THE OPERATION OF PUSHING THE PRESSURIZED SYSTEM TO THE DEVELOPING SYSTEM AND INSERTING THE DEVELOPING SYSTEM INTO THE AORTA (AFTER USING THE ACTUATOR), THE OPENING OF THE AORTA COULD NOT BE COMPLETELY CLOSED BY THE PRESSURIZED SYSTEM. JUDGED THAT THE PUSH-THROUGH WAS POORLY DEPLOYED, THE SURGEON JUDGED THAT THERE WAS A PROBLEM, AND REMOVED THE PRESSURE SEAL WITH THE CONDITION SPRING REMAINING IN THE TUBE OF THE VACUUM SYSTEM. (THUS, IT IS POSSIBLE THAT SUFFICIENT PRESSURE ADJUSTMENT WAS NOT PERFORMED ON THE PRESSURE SEAL.) HOSPITAL SAW BLEEDING FOR A MOMENT, BUT PRESSED THE OPENING WITH FINGER AND KEPT IT TO A MINIMUM. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.