OPTICROSS HD 8668

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 2020-03-17 for OPTICROSS HD 8668 manufactured by Boston Scientific Corporation.

Event Text Entries

[183879832] It was reported that sheath detachment occurred. Intravascular ultrasound (ivus) was performed twice with an opticross imaging catheter. During the third usage it noted that the tip marker remained in the patient because the outer sheath had separated. The separated outer sheath was retrieved using an extension catheter and balloon. The procedure was completed with another of same device. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03478
MDR Report Key9845783
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-12-05
Date Added to Maude2020-03-17
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 HD
Generic NameCATHETER, ULTRASOUND, INTRAVASCULAR
Product CodeOBJ
Date Received2020-03-17
Model Number8668
Catalog Number8668
Lot Number0024859935
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 2020-03-17

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