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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8655
Device Problem Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
Event Date 06/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a cancelled procedure occurred.An opticross imaging catheter was selected for use to view the target lesion.Overload was displayed during preparation outside the patients body.It was tried to restart and advanced inside the patients body, however overload was displayed again.The procedure was performed by replacing with another of same device.Subsequently, overload was also displayed using the second device outside the patients body.No patient complications were reported.
 
Event Description
It was reported that a cancelled procedure occurred.An opticross imaging catheter was selected for use to view the target lesion.Overload was displayed during preparation outside the patients body.It was tried to restart and advanced inside the patients body, however overload was displayed again.The procedure was performed by replacing with another of same device.Subsequently, overload was also displayed using the second device outside the patients body.No patient complications were reported.It was further reported that ivus was discontinued due to the overload issue, however, the procedure itself was successfully completed and the patients status is good.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.No visual damages were encountered upon visual inspection.The distal housing of the transducer was observed complete and with no shattered pieces.Functional testing identified a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.No issues or defects were observed during product analysis of the returned device.E1: initial reporter city - (b)(4).
 
Event Description
It was reported that a cancelled procedure occurred.An opticross imaging catheter was selected for use to view the target lesion.Overload was displayed during preparation outside the patients body.It was tried to restart and advanced inside the patients body, however overload was displayed again.The procedure was performed by replacing with another of same device.Subsequently, overload was also displayed using the second device outside the patients body.No patient complications were reported.Device evaluated by mfr: the device was returned for analysis.No visual damages were encountered upon visual inspection.The distal housing of the transducer was observed complete and with no shattered pieces.Functional testing identified a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.No issues or defects were observed during product analysis of the returned device.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.No visual damages were encountered upon visual inspection.The distal housing of the transducer was observed complete and with no shattered pieces.Functional testing identified a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.The catheter was properly recognized by the imaging system when plugged into the mdu and no connection issues or errors were detected during its testing.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.No issues or defects were observed during product analysis of the returned device.Patient codes corrected.E1: initial reporter city - (b)(6).
 
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Brand Name
OPTICROSS
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10190230
MDR Text Key196272387
Report Number2134265-2020-08454
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2021
Device Model Number8655
Device Catalogue Number8655
Device Lot Number0025184142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2020
Date Manufacturer Received09/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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