MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800180
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4-premarket / 510(k) #: k160514, k222568.Detailed product information was not provided to bsc.We are still waiting to obtain the information through good faith effort.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the catheter became tangled and separated, requiring intervention.An opticross 18 vascular imaging catheter was used for a peripheral intervention procedure for arterial disease.During the procedure, the catheter twisted around itself in the body and then separated.The procedure was not completed, and the patient was there were no patient complications as a result of this event.
Event or Problem Description
It was reported that the catheter became tangled and separated, requiring intervention.An opticross 18 vascular imaging catheter was used for a peripheral intervention procedure for arterial disease.During the procedure, the catheter twisted around itself in the body and then separated.The procedure was not completed, and the patient was already sedated with general anesthesia.The patient was transported to a nearby hospital to remove the catheter through surgery and was admitted to the hospital.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Correction report is being filed to update h6 (impact codes).G4-premarket / 510(k) #: k160514, k222568 detailed product information was not provided to bsc.Per the source, this information was not available.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the catheter became tangled and separated, requiring intervention.An opticross 18 vascular imaging catheter was used for a peripheral intervention procedure for arterial disease.During the procedure, the catheter twisted around itself in the body and then separated.The procedure was not completed, and the patient was already sedated with general anesthesia.The patient was transported to a nearby hospital to remove the catheter through surgery and was admitted to the hospital.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Correction report is being filed to update h6 (device codes).G4-premarket / 510(k) #: k160514, k222568.Detailed product information was not provided to bsc.Per the source, this information was not available.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Per the source, this information was not available.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The opticross 18 was not returned but device analysis was performed using the photo received.The media attached shows the issues of catheter twist and detachment.
Event or Problem Description
It was reported that the catheter became tangled and separated, requiring intervention.An opticross 18 vascular imaging catheter was used for a peripheral intervention procedure for arterial disease.During the procedure, the catheter twisted around itself in the body and then separated.The procedure was not completed, and the patient was already sedated with general anesthesia.The patient was transported to a nearby hospital to remove the catheter through surgery and was admitted to the hospital.There were no patient complications as a result of this event.

• Brand Name: OPTICROSS 18
• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21808008
• Report Number: 2124215-2025-20636
• Device Sequence Number: 21041414
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: (01)08714729904366
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160514
• 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,Followup,Followup
• Report Date (Section B): 06/23/2025

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 Model Number: H7493932800180
• Device Catalogue Number: H7493932800180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/02/2025; 05/28/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/01/2025; 05/28/2025; 06/23/2025
• 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
• Patient Sex: Unknown