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

Model Number 8668

Device Problems Poor Quality Image (1408); 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 08/04/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that visualization issues occurred.An opticross hd imaging catheter was advanced for ultrasound examination of the target lesion, but the device could not show the image and first scope was not recognized.The procedure was completed with a different device.There were no patient complications reported and the patient condition following the procedure was stable.However, device analysis revealed tip detachment.

Manufacturer Narrative

The device was returned for analysis.During visual inspection sheath kinked and tip detached tip.Impedance testing showed an electrical open distal wave form between 0-10 cm from the distal housing the transducer level impedance test with the microprobe could not be performed due to the condition of the transducer/distal housing.Microscope inspection revealed tip detached.

• Brand Name: OPTICROSS HD
• 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: 18178837
• MDR Text Key: 328634717
• Report Number: 2124215-2023-64398
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: HR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0031202933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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