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

Model Number 44021

Device Problems Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 31jan2024.It was reported that visualization issues occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified distal superficial femoral artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion but during insertion, the image was dark.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed the imaging window was twisted.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the imaging window was twisted, the drive shaft was broken, and there was imaging core windup beginning 26.3 cm from the distal end of the connector shaft.Impedance testing showed an electrical open at the proximal end of the catheter.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed the imaging window was twisted, the drive shaft was broken, and there was imaging core windup beginning 26.3 cm from the distal end of the connector shaft.Impedance testing showed an electrical open at the proximal end of the catheter.

Event Description

Reportable based on device analysis completed on 31jan2024.It was reported that visualization issues occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified distal superficial femoral artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion but during insertion, the image was dark.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed the imaging window was twisted.

• 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: 18676150
• MDR Text Key: 336070175
• Report Number: 2124215-2024-07365
• 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

• Date FDA Received: 02/09/2024
• 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: 0032386421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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