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

Model Number 8668

Device Problems Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address : beilishi road no.167 fuwai hospital chinese academy of medical sciences building 1 f f1 the device was returned for analysis.Visual inspection revealed kinks in the sheath, telescope, and imaging window assembly.No imaging core windup was found with the telescope and sheath sections of the device.Visual and microscopic inspection revealed the imaging window was detached at the lap joint section.Impedance testing showed an electrical open 70-80 cm from the distal end of the catheter.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that visualization issues occurred.The 80% stenosed, 15 mm x 2.50 mm, target lesion was located in moderately tortuous and moderately calcified right coronary artery.The opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the device could not show the image.The procedure completed with another of same device.There were no patient complications reported.However, device analysis revealed the imaging window was 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: 18449677
• MDR Text Key: 332282336
• Report Number: 2124215-2023-75300
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173284
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0031884299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 74 KG