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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)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2024
Event Type  malfunction  
Event Description
It was reported that a catheter issue occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter was used without any problem.After balloon inflation and stent placement, the catheter was going to be used again for treatment evaluation.However, when the imaging button was pressed for testing while the catheter was being placed on the wire outside the patient, the entire catheter became twisted as if it had become entangled with the wire.The procedure was completed with a different device.There were no reported patient complications.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the sheath assembly was kinked and the imaging window was twisted.Based on the evidence, the as reported code of catheter material twisted can be confirmed.
 
Event Description
It was reported that a catheter issue occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter was used without any problem.After balloon inflation and stent placement, the catheter was going to be used again for treatment evaluation.However, when the imaging button was pressed for testing while the catheter was being placed on the wire outside the patient, the entire catheter became twisted as if it had become entangled with the wire.The procedure was completed with a different device.There were no reported patient complications.
 
Manufacturer Narrative
Pro code (product code): corrected.
 
Event Description
It was reported that a catheter issue occurred.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter was used without any problem.After balloon inflation and stent placement, the catheter was going to be used again for treatment evaluation.However, when the imaging button was pressed for testing while the catheter was being placed on the wire outside the patient, the entire catheter became twisted as if it had become entangled with the wire.The procedure was completed with a different device.There were no reported patient complications.
 
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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 Key18839811
MDR Text Key336924989
Report Number2124215-2024-13050
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 04/03/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/05/2024
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 Number0032386421
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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