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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 44021
Device Problems Entrapment of Device (1212); Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2020
Event Type  malfunction  
Event Description
It was reported that catheter entanglement occurred.An opticross imaging catheter was selected for use on the severly calcified lesion.It was noted that during the procedure, lost image had occurred during pullback because the tip of the catheter got caught on the edge of the stent and the screen became black.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection observed that guide wire exit hole had damage.In order to inspect for imaging core indup at the proximal end of the catheter, the hub rotator retainer clip was removed.The rotator and imaging core assembly were pulled out from the removed hub.Imaging core windup began 22.0cm and 22.5cm from the distal end of the connector shaft.No other visual damages were encountered upon visual inspection.The distal housing of the transducer was observed complete and with no shattered pieces.The guidewire exit port was observed damaged.The mdu and ilab system were used to perform a functional inspection on the device along with the above referenced calibrated equipment.Impedance testing revealed an electrical open at proximal wave form.During image characterization testing, no image appeared in the ilab system.
 
Event Description
It was reported that catheter entanglement occurred.An opticross imaging catheter was selected for use on the severly calcified lesion.It was noted that during the procedure, lost image had occurred during pullback because the tip of the catheter got caught on the edge of the stent and the screen became black.The procedure was completed with another of the same device.No patient complications were reported.
 
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Brand Name
OPTICROSS 18
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10283986
MDR Text Key199109018
Report Number2134265-2020-09373
Device Sequence Number1
Product Code ITX
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
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/05/2022
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0025314271
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2020
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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