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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); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2023
Event Type  malfunction  
Event Description
It was reported that the device became stuck on the guidewire.The 99% stenosed target lesion was mildly tortuous and severely calcified.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.While inside the patient, the opticross catheter became stuck on the guidewire.The physician was able to remove both the catheter and guidewire together as a unit.Another of the same device was used to successfully complete the procedure.There were no patient complications.
 
Manufacturer Narrative
The device was returned for analysis.Visual and microscope inspection revealed the imaging window was twisted at the lap joint section, and at 7.5 cm from the lap joint section.Microscope inspection also revealed the guidewire exit port was damaged, but the tip was in good condition.
 
Event Description
It was reported that the device became stuck on the guidewire.The 99% stenosed target lesion was mildly tortuous and severely calcified.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.While inside the patient, the opticross catheter became stuck on the guidewire.The physician was able to remove both the catheter and guidewire together as a unit.Another of the same device was used to successfully complete the procedure.There were no patient complications.
 
Event Description
It was reported that the device became stuck on the guidewire.The 99% stenosed target lesion was mildly tortuous and severely calcified.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.While inside the patient, the opticross catheter became stuck on the guidewire.The physician was able to remove both the catheter and guidewire together as a unit.Another of the same device was used to successfully complete the procedure.There were no patient complications.
 
Manufacturer Narrative
D2b: pro code (product code) : corrected.The device was returned for analysis.Visual and microscope inspection revealed the imaging window was twisted at the lap joint section, and at 7.5 cm from the lap joint section.Microscope inspection also revealed the guidewire exit port was damaged, but the tip was in good condition.
 
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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 Key18279074
MDR Text Key329916799
Report Number2124215-2023-68841
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 Received12/06/2023
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 Number0031955114
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 Manufactured07/06/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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