MAUDE MDR 7428574

MDR report key
7428574
Report number
3009600098-2018-00008
Event key
0
Event type
3
Date of event
2018-03-29
Date received
2018-04-13
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#

Contact
DENISE JOHNSON
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
1DRAGONFLY? OPTIS? CATHETERDFII KITBOX OUS (NO SYRINGE)ST. JUDE MEDICALORDC408641C4086416207022Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-1301. O

Event Narratives#

D

Patient 1

THE FIRST DRAGONFLY OPTIS CATHETER WAS PURGED WITH CONTRAST USING A SYRINGE BEFORE CONNECTING THE DEVICE TO THE DOC, THERE WAS LESS RESISTANCE FELT COMPARED TO USUAL, AND THE CONTRAST FLOWED OUT FROM THE TIP OF THE DEVICE TOO SMOOTHLY. AFTER CROSSING THE DEVICE INTO THE LAD LESION AND WHEN THE DEVICE WAS PURGED WITH THE SYRINGE BEFORE A PULLBACK, AIR BUBBLES CAME OUT FROM THE DEVICE CATHETER. THE AIR BUBBLE WAS CONFIRMED ON ANGIOGRAM; AND FLOWED THROUGH THE CORONARY ARTERY. IT APPEARED TO BE THE DIAMETER OF THE CORONARY VESSEL (3MM). THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS, ST ELEVATION WAS OBSERVED ON AN ELECTROCARDIOGRAM AND EXPERIENCED CHEST PAIN. AFTER TEN MINUTES THE AIR BUBBLE DISAPPEARED AND THE PATIENT'S SYMPTOMS WERE RESOLVED. THEY STOPPED USING THE DEVICE AND A SECOND DRAGONFLY OPTIS CATHETER WAS PURGED BEFORE CONNECTING TO THE DOC, BUT THERE WAS LESS RESISTANCE FELT WITH THIS DEVICE ALSO. A NON-ABBOTT DEVICE WAS USED INSTEAD TO CONTINUE AND COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS EXPECTED. PATIENT SPECIFIC INFORMATION OF PATIENT IDENTIFIER, AGE OR BIRTHDATE, GENDER, AND WEIGHT ARE NOT AVAILABLE FOR THIS COMPLAINT.