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 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual and microscopic inspection revealed that the imaging window was partially detached.Since no electrical failures were noticed in the impedance analysis although the image test was not performed due to the condition in which device returned and the impedance test showed a good connection between the system and the transducer, no problem detected is the assigned cause for the reported imaging issue.Regarding the imaging window partial detachment, these are prone to occur in the lapjoint section due to the difference in rigidity between the imaging window and the sheath section.Due to this, the bending, compression and/or tensile forces that may be encountered during procedure over this section are not evenly distributed and are mainly focused over the least rigid material, in this case, the imaging window.These kinds of detachment are related to design characteristics of the device.For this reason, the assigned cause for the encountered partial detachment is cause traced to device design.All compiled information on this investigation determines that the most probable cause is: no problem detected.

Event Description

Reportable based on device analysis completed on 07mar2024.It was reported that an imaging issue occurred.The 80% stenosed target lesion was located in a moderately tortuous and moderately calcified right coronary artery.An opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, a black screen was noted.The procedure was completed using another of the same device.There were no patient complications reported.However, returned device analysis revealed that the imaging window was partially 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: 19003278
• MDR Text Key: 338896214
• Report Number: 2124215-2024-17873
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 0032099895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 89 KG