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 12/15/2023

Event Type  malfunction  

Event Description

It was reported that catheter issue occurred the 99% stenosed target lesion was located in moderately tortuous and severely calcified subclavian.The opticross catheter was advanced for ultrasound examination in the target lesion.During procedure, the tip was trapped in the lesion and the drive shaft became trapped while the image was being produced causing the image wire to break.There was no problem with the outer shaft of the catheter, and they managed to pull the catheter from the body.The procedure was completed with another of same device.There was no patient injury.

Manufacturer Narrative

D2b: pro code (product code): corrected.

Event Description

It was reported that catheter issue occurred.The 99% stenosed target lesion was located in moderately tortuous and severely calcified subclavian.The opticross catheter was advanced for ultrasound examination in the target lesion.During procedure, the tip was trapped in the lesion and the drive shaft became trapped while the image was being produced causing the image wire to break.There was no problem with the outer shaft of the catheter, and they managed to pull the catheter from the body.The procedure was completed with another of same device.There was no patient injury.

• 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: 18468168
• MDR Text Key: 332441408
• Report Number: 2124215-2024-00659
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 0031914248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1