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

Model Number 8668

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2024

Event Type  Injury  

Event Description

It was reported that a catheter issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, at the time of device delivery, a 3-point radiopaque marker was visible on angiography.After completing the imaging, it was confirmed that a radiopaque object remained in the vessel after removal of the device, which appeared to be a foreign object upon examination with optical coherence tomography (oct).The procedure was completed using a different device.No patient complications were reported.

Manufacturer Narrative

B1 adverse event/product problem, b2 outcomes attrib to adv event, and h1 type of reportable event: corrected the device was returned for analysis.Visual and microscope inspections revealed the imaging window was observed detached.Based on the evidence, the as reported code of device material separation can be confirmed.

Event Description

It was reported that a catheter issue occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, at the time of device delivery, a 3-point radiopaque marker was visible on angiography.After completing the imaging, it was confirmed that a radiopaque object remained in the vessel after removal of the device, which appeared to be a foreign object upon examination with optical coherence tomography (oct).The procedure was completed using a different device.No patient complications were reported.

• 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: 18817761
• MDR Text Key: 336794180
• Report Number: 2124215-2024-11695
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0032686895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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 Outcome(s): Other