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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2023
Event Type  malfunction  
Event Description
It was reported that device twist occurred.The 100% stenosed target lesion was located in the mildly tortuous calcified circumflex artery.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the imaging core part wrapped around the catheter inside the patient's body while manipulating the opticross.It was also said that the catheter itself rotated in the doctor's hand when it was removed.In addition, the wire from the exit port was also wrapped around the outer circumference of the catheter.The device was completely removed fully intact from the patient's body.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
E1 initial reporter city: (b)(6).
 
Manufacturer Narrative
E1 initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.The sheath assembly was kinked which can occur in the procedure during the advancement maneuvers, since in this process, the friction between the catheter and the lesion, the events description that was 100% of stenosis.Due to the reported anatomical factors, it is possible that the friction between the catheter body and the lesion caused the opposing force that kinked the sheath based on that the most probable caused to this failure is "adverse event related to patient condition".The device imaging window twisted.It was not possible to identify the cause of the issue in the catheter twist.For this reason, the cause code assign is "cause not established".
 
Event Description
It was reported that device twist occurred.The 100% stenosed target lesion was located in the mildly tortuous calcified circumflex artery.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the imaging core part wrapped around the catheter inside the patient's body while manipulating the opticross.It was also said that the catheter itself rotated in the doctor's hand when it was removed.In addition, the wire from the exit port was also wrapped around the outer circumference of the catheter.The device was completely removed fully intact from the patient's body.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
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 Key17225489
MDR Text Key318096678
Report Number2124215-2023-33771
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2023
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 Number0031322014
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2023
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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