MAUDE MDR 9638861

MDR report key
9638861
Report number
2134265-2020-00360
Event key
0
Event type
3
Date of event
2020-01-03
Date received
2020-01-28
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
JAY JOHNSON
Address
TWO SCIMED PLACE MAPLE GROVE MN 55311 US
Phone
763-763-7634
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMETTRANSDUCER, PRESSURE, CATHETER TIPBOSTON SCIENTIFIC CORPORATIONDXO890089000023066373Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2801. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. IT WAS NOTED THAT THE OSTIAL LESION OF THE BRACHIO-CEPHALIC BRANCH WAS 50% STENOSED. A 6FR NON-BSC GUIDE CATHETER ALONG WITH THIS COMET PRESSURE GUIDEWIRE WERE ADVANCED. THE FIRST LESION THAT WAS EVALUATED WAS 60% STENOSED, SLIGHTLY CALCIFIED, NON-TORTUOUS,15MM IN LENGTH AND LOCATED IN THE LEFT ANTERIOR DESCENDING. THE SECOND LESION THAT WAS EVALUATED WAS A 70-90% STENOSED, CALCIFIED SHORT OSTIAL LESION LOCATED IN THE CIRCUMFLEX. THE THIRD LESION THAT WAS EVALUATED WAS 70-90% STENOSED AND LOCATED IN THE NON-TORTUOUS, CALCIFIED, 3-5MM IN LENGTH INTERMEDIATE BRANCH. WHILE ATTEMPTING TO CROSS THE THIRD LESION THEY NOTICED THAT THE DISTAL TIP OF THE COMET PRESSURE GUIDEWIRE SEPARATED INSIDE THE GUIDE CATHETER. THERE WAS NO RESISTANCE MET WHEN THE GUIDEWIRE STOP ROTATING, AND THE TIP OF THE GUIDE CATHETER MAINTAIN POSITION IN THE OSTIUM DURING THE ENTIRE PROCEDURE. THE COMET GUIDEWIRE HAD BEEN REMOVED FROM THE PATIENT FOR RESHAPING BUT DID NOT BECOME KINKED OR PROLAPSED. THE DISTAL TIP WAS REMOVED BY TRAPPING IT INSIDE THE GUIDE CATHETER WITH 3.0X15MM NC BALLOON AT 20ATM. THE DISTAL TIP AND GUIDE CATHETER WERE REMOVED TOGETHER. ALL PARTS OF THE WIRE WERE RETRIEVED FROM THE PATIENTS BODY. NO PATIENT COMPLICATIONS WERE REPORTED THAT THE PATIENT STATUS IS STABLE. .