OPTICROSS 8655

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-05 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.

Event Text Entries

[178388761] The device was returned for analysis. Kinks were observed in the sheath assembly from femoral marker to the distal end. Kinks were observed at the lapjoint in the sheath assembly from femoral marker to the distal end. It was observed that the imaging window was found detached from the lapjoint. Windup was encountered in the non-heat shrink area of the telescope. Ic windup began 23. 60 cm from the distal end of the connector shaft. Impedance testing shows an electrical open at the proximal wave form. During image characterization testing, no image appeared in the ilab system. The flushing process cannot be preformed due to the condition of the device. The od measure of the lapjoint was within specification. Microscope inspection revealed the windup in the keyence.
Patient Sequence No: 1, Text Type: N, H10


[178388762] Reportable based on device analysis completed on 09jan2020. It was reported that lost image occured. The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery. An opticross imaging catheter was advanced to view the target lesion and the image was lost during pullback. The procedure was completed with a same device. No patient complications were reported however, returned device analysis revealed that the imaging window was detached from the lapjoint.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-01036
MDR Report Key9674124
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-05
Date of Report2020-02-05
Date of Event2019-10-24
Date Mfgr Received2020-01-09
Device Manufacturer Date2019-07-22
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street2546 CALLE PRIMERA
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTICROSS
Generic NameCATHETER, ULTRASOUND, INTRAVASCULAR
Product CodeOBJ
Date Received2020-02-05
Returned To Mfg2019-12-13
Model Number8655
Catalog Number8655
Lot Number0024145979
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.