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

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 02/19/2024

Event Type  malfunction  

Event Description

It was reported that a catheter issue occurred.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, it was noted that the catheter twisted.The procedure was completed by using another device of a different model.There were no patient complications reported.

Event Description

It was reported that a catheter issue occurred.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, it was noted that the catheter twisted.The procedure was completed by using another device of a different model.There were no patient complications reported.

Manufacturer Narrative

The device was returned for analysis.Visual and microscope inspections revealed the sheath assembly was kinked and imaging window was twisted.Based on the evidence, the as reported code of catheter material twisted can be confirmed.

Manufacturer Narrative

D2b: pro code (product code): corrected.

Event Description

It was reported that a catheter issue occurred.An opticross peripheral imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, it was noted that the catheter twisted.The procedure was completed by using another device of a different model.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: 18868747
• MDR Text Key: 337317136
• Report Number: 2124215-2024-13877
• 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,Followup
• Report Date: 04/10/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 0032377435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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