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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 01/26/2024
Event Type  malfunction  
Event Description
It was reported that a catheter issue occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound examination of the target lesion.During the procedure, the catheter got stuck with the guidewire.The physician was able to pull it out together with the guidewire.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that a catheter issue occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound examination of the target lesion.During the procedure, the catheter got stuck with the guidewire.The physician was able to pull it out together with the guidewire.The procedure was completed with another of the same device.There were no patient complications 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 Key18699442
MDR Text Key335746477
Report Number2124215-2024-07967
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 03/20/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
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 Number0032345211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2024
Initial Date FDA Received02/13/2024
Supplement Dates Manufacturer Received03/14/2024
Supplement Dates FDA Received03/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CHEVALIER FLOPPY NIPRO GUIDEWIRE; CHEVALIER FLOPPY NIPRO GUIDEWIRE
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