FDA.reportPublic FDA data

MAUDE MDR 9888444

MDR report key
9888444
Report number
3005334138-2020-00134
Event key
0
Event type
3
Date of event
2020-03-09
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEPHANIE O' SULLIVAN
Address
5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SWARTZ? INTRODUCER, UNKNOWNTRANSSEPTAL CATHETER INTRODUCERST. JUDE MEDICALDYBR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. R

Event Narratives#

N

Patient 1

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

D

Patient 1

RELATED MANUFACTURING REFERENCE: 3005334138-2020-00135, 3005334138-2020-00138. DURING A CRYOABLATION TYPICAL ATRIAL FLUTTER PROCEDURE A PERICARDIAL EFFUSION OCCURRED. THE PATIENT WAS HEMODYNAMICALLY STABLE FOR THE DURATION OF THE PROCEDURE, HOWEVER; AFTER THE CASE A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAPHY. THE PATIENT WAS TRANSFERRED TO SURGICALLY REPAIR A PERFORATION IN THE CAVOTRICUSPID ISTHMUS. FOLLOWING SURGERY THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.