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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); Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2023
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 01nov2023.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac artery (cia) and external iliac artery.The opticross 18 jp imaging catheter was advanced for ultrasound examination of the target lesion, but the catheter got caught in the edge of the stent placed in the cia.When the device was pulled for removal, the imaging began spinning at high speed and the shaft was found to be kinked.The procedure was completed with another of the same device and there was no patient injury.However, device analysis revealed catheter twist.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed kinks in the sheath and imaging window assembly, and that there was catheter twisting beginning 22.7 cm from the lap joint section.Microscopic inspection revealed the guidewire exit port was deformed and torn 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.
 
Manufacturer Narrative
D2b: pro code (product code): corrected.The device was returned for analysis.Visual inspection revealed kinks in the sheath and imaging window assembly, and that there was catheter twisting beginning 22.7 cm from the lap joint section.Microscopic inspection revealed the guidewire exit port was deformed and torn 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
Reportable based on device analysis completed on 01nov2023.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac artery (cia) and external iliac artery.The opticross 18 jp imaging catheter was advanced for ultrasound examination of the target lesion, but the catheter got caught in the edge of the stent placed in the cia.When the device was pulled for removal, the imaging began spinning at high speed and the shaft was found to be kinked.The procedure was completed with another of the same device and there was no patient injury.However, device analysis revealed catheter twist.
 
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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 Key18085910
MDR Text Key327550435
Report Number2124215-2023-62472
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 03/14/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/07/2023
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 Number0031718199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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