MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 6; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8655
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter issue occurred.The greater than 80% stenosed target lesion was located in a moderately calcified and mildly tortuous left anterior descending artery (lad) and left circumflex artery (lcx).The opticross 6 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.After a run was performed, an attempt was made to remove the catheter, but it remained hung up in the left main.Several attempts were made to pull back the device, but it would not come back into the 6f guide catheter.An attempt was then made to remove the entire system, including the wire, but a snap was heard in the ivus catheter.The majority of the opticross 6 was removed, but when fluoroscopy was performed, the radiopaque portion of the catheter could be visualized in the left main, still on the wire.The device fragment could not come back any further than the distal left main.Another wire was than run next to the detached fragment and a balloon was sent down the vessel in a failed attempt to pin the fragment for removal.The decision was made to instead stent the detached fragment, but since different equipment was needed to complete the procedure, the decision was made to admit the patient and bring them back for another intervention doing bifurcation stenting of the left main, lad, and lcx.The patient had already been exposed to a lot of contrast and x-ray and a larger guide catheter was needed to provide room for bifurcation stenting.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that the telescope and the imaging window were kinked.Microscope inspection showed that the guidewire exit port was torn and the distal section of the tip was stretched and detached.The media returned by the customer was inspected and showed evidence of tip damage.
Event or Problem Description
It was reported that a catheter issue occurred.The greater than 80% stenosed target lesion was located in a moderately calcified and mildly tortuous left anterior descending artery (lad) and left circumflex artery (lcx).The opticross 6 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.After a run was performed, an attempt was made to remove the catheter, but it remained hung up in the left main.Several attempts were made to pull back the device, but it would not come back into the 6f guide catheter.An attempt was then made to remove the entire system, including the wire, but a snap was heard in the ivus catheter.The majority of the opticross 6 was removed, but when fluoroscopy was performed, the radiopaque portion of the catheter could be visualized in the left main, still on the wire.The device fragment could not come back any further than the distal left main.Another wire was than run next to the detached fragment and a balloon was sent down the vessel in a failed attempt to pin the fragment for removal.The decision was made to instead stent the detached fragment, but since different equipment was needed to complete the procedure, the decision was made to admit the patient and bring them back for another intervention doing bifurcation stenting of the left main, lad, and lcx.The patient had already been exposed to a lot of contrast and x-ray and a larger guide catheter was needed to provide room for bifurcation stenting.It was further reported that the patient was brought back, and imaging was performed using a non-boston scientific ivus.It was decided not to intervene, as the fragment appeared to be lodged in the distal left main artery.

• Brand Name: OPTICROSS 6
• Common Device Name: 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: 20135786
• Report Number: 2124215-2024-55219
• Device Sequence Number: 12582214
• Product Code: OBJ
• UDI-Device Identifier: 08714729904762
• UDI-Public: 08714729904762
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2026
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0033491178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male