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

Model Number 8655

Device Problems Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was returned for analysis.Visual inspection revealed the imaging window was detached and was not returned for analysis.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Impedance testing showed no electrical issues with the device.

Event Description

Reportable based on device analysis completed on (b)(6).2024.It was reported that visualization issues occurred.The 90% stenosed, 3.50 x 15mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.After a stent was implanted, the opticross imaging catheter was advanced for ultrasound examination of stent apposition.The transducer could not rotate and there was no image even after repeated attempts to reconnect and re-start.The device was removed, and the procedure completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.However, device analysis revealed the imaging window was detached.

• Brand Name: OPTICROSS
• 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: 18615279
• MDR Text Key: 334280197
• Report Number: 2124215-2024-05281
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: 08714729890393
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161125
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0032079761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 55 KG