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 2020-03-12 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.

Event Text Entries

[183177269] Device evaluated by mfr. : the device was returned for analysis. Visual inspection revealed that a kink was observed in the imaging core. The imaging window was detached from the sheath assembly. The distal housing of the transducer appears to be in good condition. The imaging core was fully retracted and fully advanced. Impedance testing shows a good unit wave form. Ilab testing could not be performed due to the detachment of the imaging window. No other issues or defects were observed during product analysis of the returned device.
Patient Sequence No: 1, Text Type: N, H10


[183177270] Reportable based on device analysis completed on 21feb2020. It was reported that lost image occurred. A percutaneous coronary intervention was being performed. The 95% stenosed target lesion was located in the severely calcified left anterior descending with 50 mm in length and 3. 0 mm vessel diameter. An opticross imaging catheter was selected for use. During a percutaneous coronary intervention, it was noted that the catheter could not show the image. The procedure was completed with another of the same device. No patient complications were reported. However, device analysis noted that the imaging window was detached from the sheath assembly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03125
MDR Report Key9825361
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2020-01-09
Date Mfgr Received2020-02-21
Device Manufacturer Date2019-06-21
Date Added to Maude2020-03-12
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 Received2020-03-12
Returned To Mfg2020-01-22
Model Number8655
Catalog Number8655
Lot Number0023992634
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 2020-03-12

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