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 06/16/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 27oct2023.It was reported that visualization issues occurred.The 80% stenosed, 12mm long, blood vessel diameter 3.00mm target lesion was located in the moderately tortuous and severely calcified right coronary artery.An opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the device could not show the image.The procedure was completed with another of the same device.No patient complications were reported, and the patient status was stable.However, device analysis revealed detachment on the imaging window in the lapjoint section.

Manufacturer Narrative

E1 initial reporter facility name: (b)(6) hospital.The device was returned for analysis.Visual inspection revealed that the device returned with the imaging widow detached in the lapjoint section, it's important to mention that the imaging window was not returned for analysis.A kink was observed in the sheath assembly.An impedance inspection observed electrical failure due to an electrical open at distal wave form.Microscope inspection observed the device returned with the imaging widow detached in the lapjoint section.The transducer level impedance test with the microprobe couldn't be performed due to the superficial condition of the transducer.

• 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: 18141931
• MDR Text Key: 328188292
• Report Number: 2124215-2023-62344
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0031121268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 89 KG