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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2023
Event Type  malfunction  
Event Description
It was reported that a catheter issue occurred.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the screen went black, and the image was lost.The opticross catheter then became stuck in the lesion while attempting to cross the lesion.The device was removed from the patient, and the procedure was successfully completed using another of the same device.There were no patient complications.
 
Event Description
It was reported that a catheter issue occurred.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the screen went black, and the image was lost.The opticross catheter then became stuck in the lesion while attempting to cross the lesion.The device was removed from the patient, and the procedure was successfully completed using another of the same device.There were no patient complications.It was further reported that the catheter got stuck in the vessel, there was strong resistance and there was no additional treatment is required.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed kinked in the sheath, telescope and imaging window assembly.Catheter twist began 21.5cm from the lap joint section.Impedance test revealed good unit wave form.Microscopic inspection revealed the catheter twist began 20cm from the lap joint section.The guidewire exit port was deformed, but the tip was in good condition.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.
 
Event Description
It was reported that a catheter issue occurred.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the screen went black, and the image was lost.The opticross catheter then became stuck in the lesion while attempting to cross the lesion.The device was removed from the patient, and the procedure was successfully completed using another of the same device.There were no patient complications.It was further reported that the catheter got stuck in the vessel, there was strong resistance and there was no additional treatment is required.
 
Manufacturer Narrative
D2b: pro code (product code) : corrected.The device was returned for analysis.Visual inspection revealed kinked in the sheath, telescope and imaging window assembly.Catheter twist began 21.5cm from the lap joint section.Impedance test revealed good unit wave form.Microscopic inspection revealed the catheter twist began 20cm from the lap joint section.The guidewire exit port was deformed, but the tip was in good condition.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.
 
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Brand Name
OPTICROSS 18
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18243157
MDR Text Key329454363
Report Number2124215-2023-67236
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/19/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0031914252
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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