FDA.reportPublic FDA data

MAUDE MDR 8120621

MDR report key
8120621
Report number
1721279-2018-00165
Event key
0
Event type
3
Date of event
2018-11-07
Date received
2018-11-30
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
MISS CATHERINE EATON
Address
9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US
Phone
719-719-7194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETERELCATHE SPECTRANETICS CORPORATIONLPC110-004110-004FG018G02AR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-3001. D; 2. H; 3. L; 4. R

Event Narratives#

N

Patient 1

ALTHOUGH REQUESTED THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. THERE IS NO ALLEGATION OF A MALFUNCTION OF THE ELCA DEVICE.

D

Patient 1

A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CORONARY VASCULAR INTERVENTION PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, A SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER 110-004 DEVICE WAS USED, AND THE DIAGONAL OF THE LAD VESSEL WAS PERFORATED. THE PHYSICIAN PLACED A COVER STENT AND THE PATIENT WAS TRANSPORTED TO THE OPERATING ROOM FOR SURGERY. THE PATIENT SURVIVED THE PROCEDURE. THERE IS NO ALLEGATION OF A MALFUNCTION OF THE ELCA DEVICE.

N

Patient 1

DURING A REVIEW OF FDA WEBSITE ON (B)(6) 2019, IT WAS DISCOVERED THAT A MEDSUN ENTRY WAS PRESENT FOR THIS COMPLAINT EVENT. ON (B)(6) 2019, MANUFACTURER RECEIVED HARD COPY OF THE MEDSUN REPORT PERTAINING TO THIS COMPLAINT EVENT (REPORT # (B)(4)); BOTH REPORTED THAT PATIENT DIED TWO DAYS AFTER THE PROCEDURE. THIS FOLLOW UP MDR IS BEING SUBMITTED TO, CAPTURE THE FACT THAT THE PATIENT DIED.