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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 Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
It was reported that a catheter issue occurred.The 99% stenosed target lesion is located in the moderately tortuous and severely calcified iliac artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, severe resistance was encountered at the occluded part of the lesion.The catheter shaft became twisted and as there was a possibility that a lost image occurred, the device was removed along with the wire.The procedure was completed with another of same device.No patient complications were reported.
 
Event Description
It was reported that a catheter issue occurred.The 99% stenosed target lesion is located in the moderately tortuous and severely calcified iliac artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, severe resistance was encountered at the occluded part of the lesion.The catheter shaft became twisted and as there was a possibility that a lost image occurred, the device was removed along with the wire.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the sheath and imaging window assembly were kinked.Microscopic inspection revealed the imaging window was twisted, and the guidewire exit port and tip were 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 Key18981432
MDR Text Key338757489
Report Number2124215-2024-18159
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 Other,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/03/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/26/2024
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 Number0033092185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2023
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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