FDA.reportPublic FDA data

MAUDE MDR 9808335

MDR report key
9808335
Report number
2134265-2020-02815
Event key
0
Event type
3
Date of event
2020-01-14
Date received
2020-03-09
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
1OPTICROSSCATHETER, ULTRASOUND, INTRAVASCULARBOSTON SCIENTIFIC CORPORATIONOBJ865586550024355250Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-090

Event Narratives#

N

Patient 1

(B)(6). THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THE DISTAL SHAFT WAS SEPARATED FROM PROXIMAL SHAFT AT THE LAP JOINT IN THE SHEATH ASSEMBLY. THE IMAGING CORE WAS RETURNED KINKED IN THE DETACHMENT SECTION. IMAGING CORE WINDUP BEGAN 22.5 CM FROM THE DISTAL END OF THE CONNECTOR SHAFT. NO OTHER VISUAL DAMAGES WERE ENCOUNTERED UPON VISUAL INSPECTION. IMPEDANCE TESTING SHOWS AN ELECTRICAL OPEN AT THE PROXIMAL WAVE FORM. IMAGE CHARACTERIZATION TESTING WAS NOT PERFORMED DUE TO DEVICE CONDITION. DIMENSIONAL TEST WAS PERFORMED AND THE MEASURE WAS WITHIN SPECIFICATION.

D

Patient 1

REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2020. IT WAS REPORTED THAT LOST IMAGE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS PREPPED FOR USE WITHOUT ISSUE. DURING THE PROCEDURE, THE SCREEN BECAME BLACK AND NOTHING APPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DEVICE FRACTURE.