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

Model Number 44021

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed a kink in the telescope assembly, and catheter twist beginning 2.5 cm from the lap joint.No damages or failures were observed on the catheter code printed circuit board assembly.The catheter was properly recognized by the imaging system when plugged into the motor drive unit and no connection issues or errors were detected during its testing.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that a catheter issue occurred.The chronic total occlusion target lesion spanned the entire length of the left superficial femoral artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.After the lesion was crossed, the catheter was connected to the imaging system, but the catheter was not recognized.The system was turned off and restarted again, but the catheter was still not recognized.The procedure was completed with another of the same device.There was no patient injury.However, device analysis revealed the catheter was twisted.

Event Description

Eportable based on device analysis completed on 15nov2023.It was reported that a catheter issue occurred.The chronic total occlusion target lesion spanned the entire length of the left superficial femoral artery.The opticross 18 imaging catheter was advanced for ultrasound examination of the target lesion.After the lesion was crossed, the catheter was connected to the imaging system, but the catheter was not recognized.The system was turned off and restarted again, but the catheter was still not recognized.The procedure was completed with another of the same device.There was no patient injury.However, device analysis revealed the catheter was twisted.

Manufacturer Narrative

D2b: pro code (product code) : corrected.The device was returned for analysis.Visual inspection revealed a kink in the telescope assembly, and catheter twist beginning 2.5 cm from the lap joint.No damages or failures were observed on the catheter code printed circuit board assembly.The catheter was properly recognized by the imaging system when plugged into the motor drive unit and no connection issues or errors were detected during its testing.

• 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: 18246567
• MDR Text Key: 329689644
• Report Number: 2124215-2023-68118
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 0031884096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2023
• 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