MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

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.

• 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 Key: 18699442
• MDR Text Key: 335746477
• Report Number: 2124215-2024-07967
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• 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 Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0032345211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CHEVALIER FLOPPY NIPRO GUIDEWIRE; CHEVALIER FLOPPY NIPRO GUIDEWIRE