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 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection revealed no issued and the device appeared to be in good condition.Microscopic inspection revealed that the imaging window was twisted and detached.Impedance testing shows an electrical open at 0-10 cm from the distal end of the catheter, but x-ray analysis showed no damage that could be related to the open.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that a catheter issue occurred.The target lesion was located in a 90% stenosed, moderately tortuous, severely calcified right coronary artery.An opticross hd imaging catheter was advanced for ultrasound examination of the target lesion but failed to show an image.The procedure was completed by using another of the same device and no patient complications were reported.However, returned device analysis revealed that the imaging window was twisted and 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: 18439920
• MDR Text Key: 331912563
• Report Number: 2124215-2023-75005
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: 08714729960768
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0031132582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG