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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 Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2023
Event Type  malfunction  
Event Description
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opti cross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the device was stuck with the guidewire.The device was removed from the patient's body along with the guidewire.The procedure was completed with another of the same device, and no patient complications were reported due to this event.
 
Manufacturer Narrative
Device analysis by mfr: the device was returned for analysis.Visual inspection revealed the imaging window was observed twisted and kinked.Microscopic inspection revealed 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 device entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opti cross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the device was stuck with the guidewire.The device was removed from the patient's body along with the guidewire.The procedure was completed with another of the same device, and no patient complications were reported due to this event.
 
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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 Key17138958
MDR Text Key317298552
Report Number2124215-2023-30985
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
Report Date 08/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2023
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 Number0031322013
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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