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 2020-02-25 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.

Event Text Entries

[181171899] It was reported that device got stuck in stent occurred. The 95% stenosed 28mm length and 3. 0mm diameter target lesion was located in the severely tortuous and severely calcified left circumflex coronary artery. During percutaneous coronary intervention, opticross imaging catheter was selected for use. However, when the device was used after stent placement, it got stuck in the middle to the distal side of the stent. The opticross imaging catheter was removed and the procedure was completed with another of the same device. There were no patient complications nor injuries were reported. The patient's condition is good and has been discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02109
MDR Report Key9752933
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2020-02-06
Date Mfgr Received2020-02-06
Device Manufacturer Date2019-11-26
Date Added to Maude2020-02-25
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 Received2020-02-25
Model Number8655
Catalog Number8655
Lot Number0024837278
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25

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